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Cyfluthrin (Bayer). August 14, 1998. Pesticide Tolerance Petition. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1998/August/Day-14/p21903.htm
[Federal Register: August 14, 1998 (Volume 63, Number 157)]
[Notices]
[Page 43705-43710]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14au98-80]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-822; FRL-6019-8]
Notice of Filing of Pesticide Petitions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-822, must
be received on or before September 14, 1998.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticides Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments
to: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically to: opp-
docket@epamail.epa.gov. Follow the instructions under ``SUPPLEMENTARY
INFORMATION.'' No confidential business information should be submitted
through e-mail.
Information submitted as a comment concerning this document may be
[[Page 43706]]
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment 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. All written
comments will be available for public inspection in Rm. 1132 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: The product manager listed in the
table below:
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Office location/
Product Manager telephone number Address
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Mark Dow...................... Rm. 214, CM #2, 703- 1921 Jefferson
305-5533, e- Davis Highway,
mail:dow.mark@epamail Arlington, VA
.epa.gov.
Bipin Gandhi (PM 22).......... Rm. 707A, CM #2, 703- 1921 Jefferson
308-8380, e- Davis Highway,
mail:gandhi.bipin@epa Arlington, VA
mail.epa.gov.
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SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemicals 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 these petitions
contain 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 supports granting of
the petition. Additional data may be needed before EPA rules on the
petition.
The official record for this notice of filing, as well as the
public version, has been established for this notice of filing under
docket control number [PF-822] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number (insert docket number) and appropriate
petition number. Electronic comments on notice may be filed online at
many Federal Depository Libraries.
List of Subjects
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated:August 5,1998.
Arnold E. Layne,
Acting Director, Registration Division, Office of Pesticide Programs.
Summaries of Petitions
Petitioner summaries of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and represent the views of
the petitioners. EPA is publishing the petition summaries verbatim
without editing them 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.
1. Bayer Corporation
PP 4F4330
EPA has received a pesticide petition (PP 4F4330) from Bayer
Corporation, 8400 Hawthorn Road, PO Box 4913, Kansas City MO, 64120-
2000 proposing pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing a tolerance for residues of cyfluthrin, (Cyano(4-fluoro-3-
phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropanecarboxylate) in or on the raw agricultural
commodity potato at 0.01 parts per million (ppm). EPA has determined
that the petition contains 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 supports granting of the petition. Additional data may be
needed before EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. The metabolism of cyfluthrin in plants is
adequately understood. Studies have been conducted to delineate the
metabolism of radiolabeled cyfluthrin in various crops all showing
similar results. 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. Cyfluthrin is the active ingredient in
the registered end-use product Baythroid 2 Emulsifiable Pyrethroid
Insecticide, EPA Reg. No. 3125-351. Data to support the proposed
tolerances have been submitted to the Agency.
B. Toxicological Profile
The database for cyfluthrin is current and complete. Toxicology
data cited in support of these tolerances include:
1. Acute toxicity. There is a battery of acute toxicity studies for
cyfluthrin supporting an overall toxicity Category II for the active
ingredient.
2. Genotoxicty. Mutagenicity tests were conducted, including
several gene mutation assays (reverse mutation and recombination assays
in bacteria and a Chinese hamster ovary(CHO)/HGPRT assay); a structural
chromosome aberration assay (CHO/sister chromatid exchange assay); and
an unscheduled DNA synthesis assay in rat hepatocytes. All tests were
negative for genotoxicity.
3. Reproductive and developmental toxicity. An oral developmental
toxicity study in rats with a maternal and fetal NOEL of 10 milligram/
kilograms/body weight/day (mg/kg/bw/day) (highest dose tested (HDT)).
An oral developmental toxicity study in rabbits with a maternal
NOEL of 20 mg/kg bw/day and a maternal lowest effect level (LEL) of 60
mg/kg bw/day, based on decreased body weight gain
[[Page 43707]]
and decreased food consumption during the dosing period. A fetal NOEL
of 20 mg/kg bw/day and a fetal LEL of 60 mg/kg bw/day were also
observed in this study. The LEL was based on increased resorptions and
increased postimplantation loss.
A 3-generation reproduction study in rats with systemic toxicity
NOELs of 7.5 and 2.5 mg/kgbw/day for parental animals and their
offspring, respectively. At HDTs, the body weights of parental animals
and their offspring were reduced.
4. Subchronic toxicity. A subchronic toxicity feeding study using
rats demonstrated a NOEL of 22.5 mg/kg bw/day, the HDT.
A 6-month toxicity feeding study in dogs established a NOEL of 5
mg/kg bw/day. The LEL was 15 mg/kg bw/day based on clinical signs and
reduced thymus weights.
5. Chronic toxicity. A 12-month chronic feeding study in dogs
established a NOEL of 4 mg/kg bw/day. The LEL for this study is
established at 16 mg/kg bw/day, based on slight ataxia, increased
vomiting, diarrhea and decreased body weight.
A 24-month chronic feeding/carcinogenicity study in rats
demonstrated a NOEL of 2.5 mg/kg bw/day and LEL of 6.2 mg/kg bw/day,
based on decreased body weights in males, decreased food consumption in
males, and inflammatory foci in the kidneys in females.
A 24-month carcinogenicity study in mice was conducted. Under the
conditions of the study there were no carcinogenic effects observed. A
24-month chronic feeding/carcinogenicity study in rats was conducted.
There were no carcinogenic effects observed under the conditions of the
study.
6. Animal metabolism. A metabolism study 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. No evidence of endocrine effects was
observed 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--Food. Dietary exposure was estimated using
Novigen's Dietary Exposure Evaluation Model (DEEMa) software; results
from field trial and processing studies; consumption data from the USDA
Continuing Surveys of Food Intake by Individuals (CSFIIs), conducted
from 1989 through 1992; and information on the percentages of the crop
treated with cyfluthrin.
Cyfluthrin is currently registered for use in alfalfa, citrus,
sweet corn, cotton, sorghum, sunflower, sugarcane, carrots, peppers,
radishes and tomatoes. In addition, it has an import tolerance for
hops. Various formulations are registered for use in food handling
establishments and in combination with another active ingredient, for
use in field corn, pop corn and sweet corn.
Considering all current registered uses with the addition of
potatoes, chronic dietary exposure estimates for the overall U.S.
population were 0.8% of the RfD (0.008 mg/kg bw/day). For the most
highly exposed population subgroup, children 1 to 6 years of age non-
nursing infants (<1 year), the exposure was estimated to be 0.000153
mg/kg bw/day, or 1.9% of the RfD.
Acute dietary exposures were estimated for the overall U.S.
population, females 13-years and older, children, ages 1-6 and 7-12
years, infants, non-nursing and nursing. The exposure was compared to
the NOEL of 20 mg/kg bw/day to estimate the Margins of Exposures
(MOEs).
For the overall U.S. population the 95th, 99th and 99.9th
percentile of exposure the MOEs were calaculated as 11,751; 6,882; and
4,439 respectively.
For women aged 13-years and older the 95th, 99th and 99.9th
percentile of exposure the MOEs were calculcated as 19,719; 13,147 and
7,165 respectively.
Lastly, for the potentially highest exposed population subgroup,
non-nursing infants, the 95th, 99th and 99.9th percentile of exposure
to the MOEs were calculated at 6,201; 4,595; and 2,933, respectively.
2. 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.
A screening evaluation of leaching potential of a typical
pyrethroid was conducted using EPA's Pesticide Root Zone Model (PRZM3).
Based on this screening assessment, the potential concentrations of a
pyrethroid in ground water at 2 meters are essentially zero (<0.001
parts per billion (ppb)). Surface water concentrations for pyrethroids
were estimated using PRZM3 and Exposure Analysis Modeling System
(EXAMS) using Standard EPA cotton runoff and Mississippi pond
scenarios. The maximum concentration predicted in the simulated pond
was 52 parts per trillion (ppt). Concentration in actual drinking water
would be much lower. Based on these analyses, the contribution of water
to the dietary risk estimate is negligible.
3. 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
(FQPA) of 1996 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 dose no-
observed-effect-level (NOEL). Results for each potential exposed
subpopulation (of adults, children 1-6 years, and infants <1 year) were
compared to the systemic absorbed dose NOEL for cyfluthrin to provide
estimates of MOE.
The large MOEs for cyfluthrin clearly demonstrate a substantial
degree of safety. The total non-dietary MOEs are 3,800, 2,600, and
2,400 for adults, children (1-6 years), and infants (<1 year),
respectively. When chronic dietary exposure is aggregated with non-
dietary exposure, the aggregate MOE for adults is relatively unchanged
approximately 3,800 and the MOEs for infants and children exceed 2,400.
The non-dietary methods used in the analyses can be characterized
as highly conservative. This is due to the conservatism inherent in the
calculation procedures and input assumptions. An
[[Page 43708]]
example of this is the conservatism inherent in the jazzercise
methodology over representation of residential post-application
exposures. It is important to acknowledge that these MOEs are likely to
significantly underestimate actual MOEs due to a variety of
conservative assumptions and biases inherent in the derivatization of
exposure by this method. Therefore, it can be concluded that large MOEs
associated with potential non-dietary and aggregate exposures to
cyfluthrin will result in little or no health risks to exposed persons.
The aggregate risk analysis demonstrates compliance with the health-
based requirements of the FQPA of 1996 and supports the continued
registration and use of residential, commercial, and agricultural
products containing 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 at 62 FR 42020 (August 4, 1997) 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
uses will utilize less than 2% of the RfD 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% of the 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. MOE 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. In assessing the potential for additional
sensitivity of infants and children to residues of cyfluthrin, the data
from developmental studies in both rat and rabbit and a 2-generation
reproduction study in the rat can be considered. The developmental
toxicity studies evaluate any potential adverse effects on the
developing animal resulting from pesticide exposure of the mother
during prenatal development. The reproduction study evaluates any
effects from exposure to the pesticide on the reproductive capability
of mating animals through 2-generations, as well as any observed
systemic toxicity.
The toxicology data which support these tolerances include:
toxicity study in rats with a maternal and fetal NOEL of 10 mg/kg bw/
day (HDT).
An oral developmental toxicity study in rabbits with a maternal
NOEL of 20 mg/kg bw/day and a maternal LEL of 60 mg/kg bw/day, based on
decreased body weight gain and decreased food consumption during the
dosing period. A fetal NOEL of 20 mg/kg bw/day and a fetal LEL of 60
mg/kg bw/day were also observed in this study. The LEL was based on
increased resorptions and increased postimplantation loss.
An oral developmental toxicity study performed with beta-
cyfluthrin, the resolved isomer mixture of cyfluthrin, has been
submitted to the Agency and is currently under review.
A developmental toxicity study in rats exposed via inhalation to
liquid aerosols of cyfluthrin revealed developmental toxicity, but only
in the presence of maternal toxicity. The developmental NOEL was 0.46
mg/m3 on the basis of reduced placental and fetal weights, and delayed
ossification. The NOEL for overt maternal toxicity was <0.46 mg/m3, the
LDT.
A 3-generation reproduction study in rats with systemic toxicity
NOELs of 7.5 and 2.5 mg/kg bw/day for parental animals and their
offspring, respectively. At HDLs, the body weights of parental animals
and their offspring were reduced. Another multiple-generation
reproduction study in rats has been submitted to the Agency and is
currently under review.
The Agency used the rabbit developmental toxicity study with a
maternal NOEL of 20 mg/kg bw/day to assess acute dietary exposure and
determine a MOE for the overall U.S. population and certain subgroups.
Since this toxicological endpoint pertains to developmental toxicity
the population group of concern for this analysis was women aged 13 and
above, the subgroup which most closely approximates women of child-
bearing age. The MOE is calculated as the ratio of the NOEL to the
exposure. The Agency calculated the MOE to be over 600. The Tier III
acute dietary analysis calculated an MOE over 7,000 for this age group.
Generally, MOE's greater than 100 for data derived from animal studies
are regarded as showing no appreciable risk.
FFDCA Section 408 provides that EPA may apply an additional safety
factor for infants and children in the case of threshold effects to
account for pre- and post-natal effects and the completeness 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, 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 MOE
in excess of 2,500. 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 no Codex maximum residue levels (MRLs) currently
established for residues of cyfluthrin on potatoes commodities.
The available data indicate that there is reasonable certainty of
no harm from the aggregate exposure from all currently registered uses
of cyfluthrin. Thus consistent with the provisions of the FFDCA as
amended August 3, 1996, the time limitations on established cyfluthrin
tolerance should be removed. (Mark Dow).
[FR Doc. 98-21903 Filed 8-13-98; 8:45 am]
BILLING CODE 6560-50-F