[Federal Register Volume 66, Number 31 (Wednesday, February 14, 2001)]
[Notices]
[Pages 10289-10292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3621]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-998; FRL-6768-7]


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-998, must be 
received on or before March 16, 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-998 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-6100; e-mail address: 
[email protected].

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'' 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-998. 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-998 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 protected], 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-998. Electronic comments

[[Page 10290]]

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 Cosmetic 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: January 31, 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 
petitioner. 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.

FMC Corporation

0E6216

    EPA has received a pesticide petition (0E6216) from FMC 
Corporation, 1735 Market Street, Philadelphia, PA proposing, pursuant 
to section 408(d) of the (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR 
part 180 by establishing a tolerance for residues of bifenthrin ((2-
methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-
propenyl)-2,2-dimethylcyclopropanecarboxylate) in or on the raw 
agricultural commodity (RAC) bananas at 0.1 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 support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

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-2132M, (PP) 0E3921, MRID 
41658601.
    3. Magnitude of residues. Field residue trials meeting EPA study 
requirements have been conducted at the maximum label rate for the crop 
bananas. Results from these trials demonstrate that the highest 
bifenthrin residues found will not exceed 0.1 (ppm) when the product is 
applied following the proposed use directions.

B. Toxicological Profile

    1. Acute toxicity. For the purposes of assessing acute dietary 
risk, FMC Corporation has used the maternal no observed adverse effect 
level (NOAEL) of 1.0 milligram/kilogram (mg/kg)/day from the oral 
developmental toxicity study in rats. The maternal lowest effect level 
(LEL) of this study of 2.0 mg/kg/day was based on tremors from day 7-17 
of dosing. This acute dietary endpoint is used to determine acute 
dietary risks to all population subgroups.
    2. Genotoxicity. The following genotoxicity tests were all 
negative. Gene mutation in Salmonella (Ames); chromosomal aberrations 
in Chinese hamster ovary and rat bone marrow cells; hypoxanthine 
guanine phophoribosyl transferase (HGPRT) locus mutation in mouse 
lymphoma cells; and unscheduled DNA synthesis in rat hepatocytes.
    3. Reproductive and developmental toxicity. i. In the rat 
reproduction study, parental toxicity occurred as decreased body weight 
(bwt) 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 (HDT)).
    ii. Based on the absence of pup toxicity up to dose levels which 
produced toxicity in the parental animals, there is no evidence of 
special postnatal sensitivity to infants and children in the rat 
reproduction study.
    4. Subchronic toxicity--Short- and intermediate-term toxicity. The 
maternal NOAEL of 1.0 mg/kg/day from the oral developmental toxicity 
study in rats is also used for short- and intermediate-term margin of 
exposure (MOE) calculations (as well as acute, discussed in (1) above). 
The maternal LEL of this

[[Page 10291]]

study of 2.0 mg/kg/day was based on tremors from day 7-17 of dosing.
    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 LOAEL of 3.0 mg/kg/day; an 
uncertainty factor (UF) 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 
endocrine system.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. Tolerances have been established for 
the residues of bifenthrin, in or on a variety of RACs. Tolerances, in 
support of registrations, currently exist for residues of bifenthrin on 
hops, strawberries, corn grain, forage, and fodder, sweet corn, 
cottonseed, artichokes, the crop group cucurbit vegetables, the crop 
group legume vegetables - subgroup edible-podded legume vegetables, and 
subgroup succulent shelled pea, eggplant, the subgroup head and stem 
brassica, and livestock commodities of cattle, goats, hogs, horses, 
sheep, poultry, eggs, and milk. Pending tolerances for citrus, bananas, 
grapes, peanuts, pears, potatoes, caneberries, peppers (bell and non-
bell), lettuce (head), and herbs also exist. For the purposes of 
assessing the potential dietary exposure for these existing and pending 
tolerances FMC Corporation has utilized available information on 
anticipated residues, monitoring data and percent crop treated as 
follows:
    ii. Acute exposure and risk. 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 one day or single exposure. For the purposes of 
assessing acute dietary risk for bifenthrin, the maternal NOAEL of 1.0 
mg/kg/day from the oral developmental toxicity study in rats was used. 
The maternal LEL of this study of 2.0 mg/kg/day was based on tremors 
from day 7-17 of dosing. 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 was incorporated into a Tier 3 analysis; using Monte Carlo 
modeling for commodities that may be consumed in a single serving. 
These assessments show that the MOEs are greater than the EPA standard 
of 100 for all subpopulations. The 99.9th percentile of 
exposure for the overall U. S. population was estimated to be 0.005506 
mg/kg/day (MOE of 181). The 99.9th percentile of exposure 
for all infants <1-year old was estimated to be 0.005825 mg/kg/day (MOE 
of 171). The 99.9th percentile of exposure for nursing 
infants <1-year old was estimated to be 0.004056 mg/kg/day (MOE of 
246). The 99.9th percentile of exposure for non-nursing 
infants <1-year old was estimated to be 0.005910 mg/kg/day (MOE of 
169). The 99.9th percentile of exposure for children 1 to 6 
years old (the most highly exposed population subgroup) was estimated 
to be 0.009741 mg/kg/day (MOE of 102). Therefore, FMC Corporation 
concludes that the acute dietary risk of bifenthrin, as estimated by 
the dietary risk assessment, does not appear to be of concern.
    iii. Chronic exposure and risk. The acceptable reference dose (RfD) 
is based on a NOAEL of 1.5 mg/kg/day from the chronic dog study and an 
UF of 100 is 0.015 mg/kg/day. The endpoint effect of concern was 
tremors in both sexes of dogs at the LEL of 3.0 mg/kg/day. A chronic 
dietary exposure/risk assessment has been performed for bifenthrin 
using the above RfD. The chronic exposures are estimated to be 0.000186 
mg/kg bwt/day and utilize 1.2% of the RfD for the overall U. S. 
population; children 7-12 years old and children 1-6 years old 
(subgroups most highly exposed) are estimated to be 0.000229 mg/kg bwt/
day and 0.000371 mg/kg bwt/day and utilizes 1.5% and 2.5% of the RfD, 
respectively. Generally speaking, the EPA has no cause for concern if 
the total dietary exposure from residues for uses for which there are 
published and proposed tolerances is less than 100% of the RfD. 
Therefore, FMC Corporation concludes that the chronic dietary risk of 
bifenthrin, as estimated by the dietary risk assessment, does not 
appear to be of concern.
    iv. Drinking water. Laboratory and field data have demonstrated 
that bifenthrin is immobile in soil and will not leach into 
groundwater. Other data show that bifenthrin is virtually insoluble in 
water and extremely lipophilic. As a result, FMC Corporation concludes 
that residues reaching surface waters from field runoff will quickly 
adsorb to sediment particles and be partitioned from the water column. 
Further, 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 groundwater at depths of 1 and 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 0.052 ppb. 
Concentrations in actual drinking water would be much lower than the 
levels predicted in the hypothetical, small, stagnant farm pond model 
since drinking water derived from surface water would normally be 
treated before consumption. Based on these analysis, the contribution 
of water to the dietary risk estimate is negligible. Therefore, FMC 
Corporation concludes that together these data indicate that residues 
are not expected to occur in drinking water.
    2. Non-dietary exposure. Analysis were conducted which included an 
evaluation of potential non-dietary (residential) applicator, post-
application and chronic dietary aggregate exposures associated with 
bifenthrin products used for residential flea infestation control and 
agricultural/commercial applications. The aggregate analysis 
conservatively assumes that a person is concurrently exposed to the 
same active ingredient via the use of consumer or professional flea 
infestation control products and to chronic level residues in the diet.
    In the case of potential non-dietary health risks, conservative 
point estimates of non-dietary exposures, expressed as total systemic 
absorbed dose (summed across inhalation and incidental ingestion 
routes) for each relevant product use category (i.e., lawn

[[Page 10292]]

care) and receptor subpopulation (i.e., adults, children 1-6 years and 
infants <1-year) are compared to the systemic absorbed dose NOAEL for 
bifenthrin to provide estimates of the MOEs. Based on the toxicity 
endpoints selected by EPA for bifenthrin, inhalation and incidental 
oral ingestion absorbed doses were combined and compared to the 
relevant systemic NOAEL for estimating MOEs.
    In the case of potential aggregate health risks, the above 
mentioned conservative point estimates of inhalation and incidental 
ingestion non-dietary exposure (expressed as systemic absorbed dose) 
are combined with estimates (arithmetic mean values) of chronic average 
dietary (oral) absorbed doses. These aggregate absorbed dose estimates 
are also provided for adults, children 1-6 years and infants <1-year. 
The combined or aggregated absorbed dose estimates (summed across non-
dietary and chronic dietary) are then compared with the systemic 
absorbed dose NOAEL to provide estimates of aggregate MOEs.
    The non-dietary and aggregate (non-dietary + chronic dietary) MOEs 
for bifenthrin indicate a substantial degree of safety. The total non-
dietary (inhalation + incidental ingestion) MOEs for post-application 
exposure for the lawn care product evaluated was estimated to be 
194,000 for adults, 52,400 for children 1-6 years old and 56,700 for 
infants <1-year. The aggregate MOE (inhalation + incidental oral + 
chronic dietary, summed across all product use categories) was 
estimated to be 4,878 for adults, 1,117 for children 1-6 years old and 
1,361 for infants (<1-year). It can be concluded that the potential 
non-dietary and aggregate (non-dietary + chronic dietary) exposures for 
bifenthrin are associated with substantial margins of safety.

D. Cumulative Effects

    In consideration of potential cumulative effects of bifenthrin and 
other substances that may have a common mechanism of toxicity, 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. FMC Corporation intends to submit 
information for the EPA to consider concerning potential cumulative 
effects of bifenthrin consistent with the schedule established by EPA 
in the Federal Register at 62 FR 42020 (August 4, 1997), FRL-5734-6 and 
other EPA publications pursuant to the Food Quality Protection Act.

E. Safety Determination

    1. U.S. population. For the overall U.S. population, the calculated 
MOE at the 95th percentile was estimated to be 650, 359 at 
the 99th percentile; and 181 at the 99.9th 
percentile. For all infants <1-year old, the calculated MOE at the 
95th percentile was estimated to be 540; 241 at the 
99th percentile; and 171 at the 99.9th 
percentile. For nursing infants <1-year old, the calculated MOE at the 
95th percentile was estimated to be 1,311; 451 at the 
99th percentile; and 246 at the 99.9th 
percentile. For non-nursing infants <1-year old, the calculated margins 
of exposure MOE at the 95th percentile was estimated to be 
476, 197 at the 99th percentile; and 169 at the 
99.9th percentile. For the most highly exposed population 
subgroup, children 1-6 years old, the calculated MOE at the 
95th percentile was estimated to be 330, 214 at the 
99th percentile; and 102 at the 99.9th 
percentile. Therefore, FMC Corporation concludes that there is 
reasonable certainty that no harm will result from acute exposure to 
bifenthrin.
    2. Infants and children--a. General. In assessing the potential for 
additional sensitivity of infants and children to residues of 
bifenthrin, FMC Corporation considered data from developmental toxicity 
studies in the rat and rabbit, and a 2-generation reproductive 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 pesticide on the reproductive capability of mating 
animals and data on systemic toxicity. FFDCA section 408 provides that 
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 the completeness of the data base.
    b. 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 1 mg/kg/day, based on 
tremors at the LOAEL of 2 mg/kg/day. The developmental (pup) NOAEL was 
also 1 mg/kg/day, based upon increased incidence of hydroureter at the 
LOAEL 2 mg/kg/day. There was 5/23 (22%) litters affected (5/141 fetuses 
since each litter only had one affected fetus) in the 2 mg/kg/day 
group, compared with zero in the control, 1, and 0.5 mg/kg/day groups. 
According to recent historical data (1992-1994) for this strain of rat, 
incidence of distended ureter averaged 11% with a maximum incidence of 
90%.
    c. Reproductive toxicity study. In the rat reproduction study, 
parental toxicity occurred as decreased bwt 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 HDT.
    d. Prenatal and postnatal sensitivity--i. Prenatal. Since there was 
not a dose-related finding of hydroureter in the rat developmental 
study and in the presence of similar incidences in the recent 
historical control data, the marginal finding of hydroureter in rat 
fetuses at 2 mg/kg/day (in the presence of maternal toxicity) is not 
considered a significant developmental finding. Nor does it provide 
sufficient evidence of a special dietary risk (either acute or chronic) 
for infants and children which would require an additional safety 
factor. Based on the absence of pup toxicity up to dose levels, which 
produced toxicity in the parental animals, there is no evidence of 
special postnatal sensitivity to infants and children in the rat 
reproduction study.
    e. Conclusion. Based on the above, FMC Corporation concludes that 
reliable data support use of the standard 100-fold UF, and that an 
additional UF is not needed to protect the safety of infants and 
children. As stated above, aggregate exposure assessments utilized less 
than 10% of the RfD for either the entire U. S. population or any of 
the 26 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 
residues of bifenthrin in or on bananas.
[FR Doc. 01-3621 Filed 2-13-01; 8:45 am]
BILLING CODE 6560-50-S