Bifenthrin - Notice of Filing Pesticide Petitions 2/02
ENVIRONMENTAL PROTECTION AGENCY
Notice of Filing Pesticide Petitions to Establish Tolerances for
Certain Pesticide Chemicals in or on Food
AGENCY: Environmental Protection Agency (EPA).
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 docket control number PF-1069, must be
received on or before March 18, 2002.
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-1069, in the subject line on the first page of your
FOR FURTHER INFORMATION CONTACT: By mail: Susan Stanton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5218; e-mail address:
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
Categories NAICS codes potentially
Industry 111 Crop production
112 Animal production
311 Food 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
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" 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-1069. 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
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-1069 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: email@example.com, 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-1069. 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
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
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
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
II. What Action is the Agency Taking?
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 Cosmetic 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 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
Dated: February 5, 2002.
Richard P. Keigwin, Jr.
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 summaries announce 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.
FMC Corporation, Interregional Research Project Number 4 Taipei
Economic and Cultural Representative Office
PP 0E6157; 1E6234; 1E6330, 2E6402, 2F6390, 6E4630, and 6F3454
EPA has received a pesticide petition (PP 2F6390) and an amended
pesticide petition (6F3454) from FMC Corporation, 1735 Market Street,
Philadelphia, PA 19103 proposing, pursuant to section 408(d) of the
FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180.442, by establishing
a tolerance for residues of bifenthrin, (2-methyl 1,1'-biphenyl-3-yl)
dimethylcyclopropanecarboxylate, in or on agricultural commodities as
1. PP 2F6390 proposes a tolerance in or on food products in food
handling establishments at 0.01 parts per million (ppm).
2. PP 6F3454 proposes a tolerance in or on the raw agricultural
commodity pears at 1.0 ppm, in or on almond hulls at 2 ppm and in or on
the tree nuts crop group at 0.05 ppm.
EPA also received pesticide petitions (6E4630, 0E6157, 2E6402, and
1E6330) from the Interregional Research Project Number 4 (IR-4), 681
U.S. Highway #1 South, North Brunswick, New Jersey 08902 proposing,
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40
CFR part 180.442, by establishing a tolerance for residues of
bifenthrin, in or on raw agricultural commodities as follows:
1. PP 6E4630 proposes a tolerance for the leaf petioles subgroup
(4B) (includes cardoon, celery, Chinese celery, celtuce, Florence
fennel, rhubarb, Swiss chard) at 2.0 ppm.
2. PP 0E6157 proposes a tolerance for the herb subgroup (19A) at
3. PP 1E6330 proposes a tolerance for tomato at 0.15 ppm.
4. PP 2E6402 proposes a tolerance for spinach at 0.2 ppm.
In addition, EPA received a pesticide petition (1E6234) from the
Taipei Economic and Cultural Representative Office in the United
States, 4301 Connecticut Ave., NW., Suite 420, Washington, DC 20008-
2387 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C.
346a(d), to amend 40 CFR part 180.442, by establishing an import
tolerance for residues of bifenthrin in or on carambola (starfruit) at
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 the
A. Residue Chemistry
1. Plant metabolism. The metabolism of bifenthrin in plants is
adequately understood. Studies have been conducted to delineate the
metabolism of radiolabelled bifenthrin in various crops all showing
similar results. The residue of concern is the parent compound only.
2. Analytical method. There is a practical analytical method for
detecting and measuring levels of bifenthrin in or on food with a limit
of detection that allows monitoring of food with residues at or above
the levels set in these tolerances Gas Chromatography with Electron
Capture Detection (GC/ECD) analytical method P-2132, PP 0E3921, MRID
3. Magnitude of residues. Field residue trials meeting EPA study
requirements have been conducted at the maximum label rate for pears,
tree nuts, the herbs subgroup, the leaf petiole subgroup, spinach and
tomato. Additionally, a food handling establishment residue study was
conducted. Results from the studies demonstrate that the highest
bifenthrin residues found will not exceed the proposed tolerances when
bifenthrin is applied following the proposed use directions. In
addition, field residue trials from Taiwan were submitted in support of
the import tolerance for carambola.
B. Toxicological Profile
1. Acute toxicity. For the purposes of assessing acute dietary
risk, FMC has used the results of a recently completed oral
developmental toxicity study in rats. The maternal no observed adverse
effect level (NOAEL) is 7.4 mg/kg/day (90 ppm), and is based on
treatment-related clinical signs and reductions in body weights,
adjusted maternal body weights, and corresponding reductions in food
consumption noted among dams receiving 16.3 mg/kg/day (200 ppm). The
embryo/fetal NOAEL is in excess of 16.3 mg/kg/day (200 ppm) based on
the lack of any adverse fetal effects at levels up to and including
16.3 mg/kg/day (200 ppm). This acute dietary endpoint is used to
determine acute dietary risks to all population subgroups.
2. Genotoxicty. The mouse lymphoma mutagenesis assay gave a weak
positive result; however, the weight of the evidence from short-term
mutagenicity tests indicate that bifenthrin is not mutagenic.
3. Reproductive and developmental toxicity--i. Rat reproduction
study. Parental toxicity occurred as decreased body weight at 5.0 mg/
kg/day with a NOAEL of 3.0 mg/kg/day. There were no developmental (pup)
or reproductive effects up to 5.0 mg/kg/day (highest dose tested).
ii. Postnatal sensitivity. Based on the absence of pup toxicity up
to dose levels, which produced toxicity in the parental animals, there
was no evidence of special postnatal sensitivity to infants and
children in the rat reproduction study.
4. Subchronic toxicity. The results of the 21-day dermal toxicity
study in rats are used for short- and intermediate-term dermal risk
calculations. The 21-day dermal toxicity study NOAEL for systemic
toxicity is 50 mg/kg/day based on significant reductions in tail flick
latency and on clinical signs considered indicative of systemic
toxicity (i.e., exaggerated hindlimb flexion, exophthalmos and
staggered gait, and vocalization).
5. Chronic toxicity--i. The reference dose (RfD) has been
established at 0.015 mg/kg/day. This RfD is based on a 1-year oral
feeding study in dogs with a NOAEL of 1.5 mg/kg/day, based on
intermittent tremors observed at the lowest observed adverse effect
level (LOAEL) of 3.0 mg/kg/day; an uncertainty factor of 100 is used.
ii. Bifenthrin is classified as a Group C chemical (possible human
carcinogen) based upon urinary bladder tumors in mice; assignment of a
Q* has not been recommended.
6. Animal metabolism. The metabolism of bifenthrin in animals is
adequately understood. Metabolism studies in rats with single doses
demonstrated that about 90% of the parent compound and its hydroxylated
metabolites are excreted.
7. Metabolite toxicology. The Agency has previously determined that
the metabolites of bifenthrin are not of toxicological concern, and
need not be included in the tolerance expression.
8. Endocrine disruption. No special studies investigating potential
estrogenic or other endocrine effects of bifenthrin have been
conducted. However, no evidence of such effects was reported in the
standard battery of required toxicology studies, which have been
completed and found acceptable. Based on these studies, there is no
evidence to suggest that bifenthrin has an adverse effect on the
C. Aggregate Exposure
1. Dietary exposure. Tolerances have been established for the
residues of bifenthrin, in or on a variety of raw agricultural
commodities. Tolerances, in support of registrations, currently exist
for residues of bifenthrin on the following crops: Hops, strawberries,
corn (grain, forage and fodder), sweet corn, eggplant, cottonseed,
artichokes, peppers (bell and non-bell), lettuce (head), and grapes.
Also for the crop group cucurbit vegetables and the subgroup edible-
podded legume, succulent shelled peas, caneberries, cabbage, rapeseed
and brassica (head and stem). Also, for the livestock commodities of
cattle, goats, hogs, horses, sheep, poultry, eggs, and milk. Pending
tolerances for leafy petioles, leafy brassica, tree nuts crop group,
tomatoes, food handling establishments, citrus, bananas, peanuts,
pears, potatoes, dried shelled peas/beans, spinach, and the subgroup
herbs also exist. For the purposes of assessing the potential dietary
exposure for these existing and pending tolerances, FMC conducted an
exposure estimate using Novigen's Dietary Exposure Evaluation Model
(DEEM) software, results from field trials and processing studies,
monitoring data, consumption data from the 1994-1996, 1998 USDA
Continuing Surveys of Food Intakes by Individuals (CSFII), and
information on the percentages of the crops treated (where available)
with bifenthrin were utilized.
i. Food--a. Acute dietary exposure. 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. For the purposes of assessing acute dietary risk for
bifenthrin, the maternal NOAEL of 7.4 mg/kg/day from the recent oral
developmental toxicity study in rats was used. The maternal LOAEL of
this study of 16.3 mg/kg/day was based on treatment-related clinical
signs and reductions in body weights, adjusted maternal body weights,
and corresponding reductions in food consumption. This acute dietary
endpoint was used to determine acute dietary risks to all population
subgroups. Available information on anticipated residues, monitoring
data and percent crop treated (if no estimate was available the
conservative estimate of 100% crop treatment was used) were
incorporated into a Tier 3 analysis; using Monte Carlo modeling for
commodities that may be consumed in a single serving. These assessments
demonstrate that the MOEs at the 99.9th percentile are
greater than the EPA standard of 100 for all subpopulations. The
99.9th percentile of exposure for the overall U.S.
population is estimated to be 0.004623 mg/kg/day (MOE of 1600). The
99.9th percentile of exposure for children 1 to 6 years old
(most highly exposed population subgroup) is estimated to be 0.009573
mg/kg/day (MOE of 773). The 99.9th percentile of exposure to
all infants less than 1 year old is estimated to be 0.004535 mg/kg/day
(MOE of 1631). The 99.9th percentile of exposure for nursing
infants less than one 1 year old is estimated to be 0.002561 mg/kg/day
(MOE of 2889). The 99.9th percentile of exposure to non-
nursing infants less than 1 year old is estimated to be 0.004801 mg/kg/
day (MOE of 1541). Based on the conservatism used in the analyses,
actual dietary exposure will be less than that presented here. FMC
concludes that based on adequate MOEs for all population subgroups,
there is reasonable certainty that no harm will result from the
proposed additional uses of bifenthrin.
b. Chronic exposure. The acceptable RfD for bifenthrin, based on a
NOAEL of 1.5 mg/kg/day from the chronic dog study and an uncertainty
factor of 100 (to account for interspecies and intraspecies
variations), is 0.015 mg/kg/day. The endpoint effect of concern was
tremors in both sexes of dogs at the LOAEL of 3.0 mg/kg/day. A chronic
dietary exposure/risk assessment has been performed for bifenthrin
using the RfD of 0.015 mg/kg/day. The chronic exposures for the U.S.
population are estimated to be 0.000530 mg/kg/day and utilize 3.5% of
the RfD. The chronic exposures for children 1 to 6 years old (most
highly exposed population subgroup) is estimated to be 0.001415 mg/kg/
day and utilizes 9.4% of the RfD. Chronic dietary exposure estimates
for the overall U.S. population and 25 population subgroups (including
infants and children) are all less than 10% of the chronic RfD of 0.015
mg/kg/day, therefore, FMC concludes with reasonable certainty that no
harm will result from the proposed additional uses of bifenthrin.
ii. Drinking water. EPA's draft standard operating procedures (SOP)
for incorporating estimates of drinking water exposure into aggregate
risk assessments was used to perform a drinking water analysis. This
SOP utilizes a variety of tools to conduct drinking water assessment.
These tools include water models such as FQPA Index Reservoir Screening
Tool (FIRST), PRZM/EXAMS, SCIGROW and monitoring data. If monitoring
data are not available, then the models are used to predict potential
residues in surface water. A comparison of the calculated Drinking
Water Level of Concern (DWLOC) value to the Drinking Water Estimated
Concentration (DWEC) is made. If the DWLOC exceeds the DWEC value, then
there is reasonable certainty that no harm will result from the short-
or intermediate-term aggregate exposure. In the case of bifenthrin,
monitoring data do not exist, so the FIRST model was used to estimate a
surface water residue. Based on the analyses, the short-term DWLOCs
were greater than 530 ppb while the modeled DWEC was 14 parts per
trillion (ppt). The intermediate-term DWLOCs was greater than 1,000 ppb
while the modeled DWEC was 14 pptr. Since, the calculated DWLOC values
for short- and intermediate-term exposures for all adults, adult
females, and toddlers exceed the modeled DWEC surface water residues,
there is reasonable certainty that no harm will result from aggregate
(food, water, and residential) exposure to bifenthrin residues.
2. Non-dietary exposure. A variety of techniques are used to assess
exposure to pesticidal residues. These techniques range from utilizing
straightforward algorithms to complex exposure models. The residential
exposure algorithms and default factors in the EPA's Standard Operating
Procedures for Residential Exposure Assessments were used in this
analysis. The values used include the modifications to the default
factors presented by the EPA to the Science Advisory Panel during 2001.
The EPA also has created models and data bases to use in the absence of
adequate data such as: Pesticide Handlers Exposure Data Base (PHED).
The aggregate residential exposure analyses were based on conservative
screening-level assumptions. The residential risk assessments resulted
in acceptable MOEs and a clear indication of reasonable certainty of no
harm. The short-term analyses, all of the route- and product-specific
MOEs were greater than 1,000, and the aggregate MOEs were greater than 100.
The short-term aggregate MOEs for all adults is estimated to be 153, adult
females 131, and toddlers 235. The intermediate-term analyses, all of
the route- and product-specific MOEs were greater than 6,000, and the
aggregate MOEs were greater than 2,000. The intermediate-term aggregate
MOEs for all adults is estimated to be 4,430, adult females 4,348, and
toddlers 2,394. Based on the above information, FMC concludes that
bifenthrin does not pose a risk due to short- and intermediate-term
D. Cumulative Effects
To our knowledge there are currently no available data, or other
reliable information indicating that any toxic effects produced by
bifenthrin would be cumulative with those of other chemical compounds;
thus, only the potential risks of bifenthrin have been considered in
this assessment of its aggregate exposure.
E. Safety Determination
1. U.S. population. Using the conservative exposure assessment
analyses the estimated chronic exposure to the U.S. population is
0.000530 mg/kg/day and utilizes 3.5% of the RfD. In addition, the
chronic exposure estimates for all 25 population subgroups (including
infants and children) are well below the chronic RfD of 0.015 mg/kg/
day. The acute dietary exposure analyses at the 99.9th
percentile for the U.S. population is 0.004623 with a MOE of 1600. In
addition, the acute exposure estimates for population subgroups of
concern (women of childbearing age, infants, and children) indicate
there are adequate MOEs (greater than 100). Based on this information,
FMC concludes that there is reasonable certainty that no harm will
result from acute and chronic exposure to bifenthrin.
2. Infants and children--i. General. In assessing the potential for
additional sensitivity of infants and children to residues of
bifenthrin, FMC considered data from developmental toxicity studies in
the rat and rabbit and a two-generation reproduction study in the rat.
The developmental toxicity studies are designed to evaluate adverse
effects on the developing organism resulting from pesticide exposure
during prenatal development to one or both parents. Reproduction
studies provide information relating to effects from exposure to the
systemic toxicity. FFDCA section 408, provides that the EPA may apply
an additional margin of safety for infants and children in the case of
threshold effects to account for prenatal, and postnatal toxicity and
completeness of the data base.
ii. Developmental toxicity studies. In the rabbit developmental
study, there were no developmental effects observed in the fetuses
exposed to bifenthrin. The maternal NOAEL was 2.67 mg/kg/day based on
head and forelimb twitching at the LOAEL of 4 mg/kg/day. In the rat
developmental study, the maternal NOAEL was 7.4 mg/kg/day, based on
treatment-related clinical signs and reductions in body weights,
adjusted maternal body weights, and corresponding reductions in food
consumption noted among dams receiving the LOAEL of 16.3 mg/kg/day. The
developmental NOAEL was greater than 16.3 mg/kg/day based on lack of
any adverse fetal effects at levels up to and including 16.3 mg/kg/day.
iii. Reproductive toxicity study. In the rat reproduction study,
parental toxicity occurred as decreased body weight at 5.0 mg/kg/day
with a NOAEL of 3.0 mg/kg/day. There were no developmental (pup) or
reproductive effects up to 5.0 mg/kg/day (highest dose tested).
iv. Conclusion. Based on the absence of fetal effects and pup
toxicity in any of the referenced studies, FMC concludes that reliable
data support use of the standard 100-fold uncertainty factor, and that
an additional uncertainty factor is not needed to protect the safety of
infants and children. As previously stated, aggregate exposure
assessments utilized less than 10% of the RfD for either the entire
U.S. population or any of the population subgroups including infants
and children. Therefore, it may be concluded that there is reasonable
certainty that no harm will result to infants and children from
aggregate exposure to bifenthrin residues.
F. International Tolerances
There are no Codex, Canadian, or Mexican residue limits for the
residue of bifenthrin in or on pears, the tree nut crop group, foods in
food handling establishments, the herb subgroup, the leaf petiole
subgroup, spinach, carambola or tomato.
[FR Doc. 02-3663 Filed 2-14-02; 8:45 am]