[Federal Register Volume 66, Number 80 (Wednesday, April 25, 2001)]
[Notices]
[Pages 20811-20815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10125]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1018; FRL-6778-4]


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-1018, must be 
received on or before May 25, 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-1018 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Leonard Cole, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-5412; 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,'' ``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-1018. 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

[[Page 20812]]

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-1018 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-1018. 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 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: April 9, 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 Corp.

PP 1F6266

    EPA has received a pesticide petition (PP 1F6266) from FMC Corp., 
1735 Market Street, Philadelphia, PA 19103 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 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 citrus fruits at 0.05 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.

[[Page 20813]]

    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 
subgroup leaf petioles. Results from these trials demonstrate that the 
highest bifenthrin residues found will not exceed the proposed 
tolerance of 2.0 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 has used the maternal NOAEL of 1.0 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; HGPRT locus 
mutation in mouse lymphoma cells; and unscheduled DNA synthesis in rat 
hepatocytes.
    3. Reproductive and developmental toxicity--i.Rat reproduction 
study. Parental toxicity occurred as decreased body weight at 5.0 
milligrams/kilograms/day (mg/kg/day) with a no observed adverse effect 
level (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 
is no evidence of special postnatal sensitivity to infants and children 
in the rat reproduction study.
    4. Subchronic 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 margins of exposure (MOE) calculations (as well 
as acute, discussed in (1) above). The maternal LEL of this 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 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 
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 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 subgroups edible-
podded legume, succulent shelled peas, caneberries and brassica (head 
and stem). Also, for the livestock commodities of cattle, goats, hogs, 
horses, sheep, poultry, eggs and milk. Pending tolerances for citrus, 
bananas, peanuts, pears, potatoes, spinach and the subgroup herbs also 
exist. For the purposes of assessing the potential dietary exposure for 
these existing and pending tolerances, FMC has utilized available 
information on anticipated residues, monitoring data and percent crop 
treated as follows:
    a. 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 1 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 0.004291 mg/kg/day (MOE of 233). The 
99.9th percentile of exposure for all infants less than 1 year old was 
estimated to be 0.002903 mg/kg/day (MOE of 344). The 99.9th percentile 
of exposure for nursing infants less than 1 year old was estimated to 
be 0.002058 mg/kg/day (MOE of 485). The 99.9th percentile of exposure 
for non-nursing infants less than 1 year old was estimated to be 
0.003030 mg/kg/day (MOE of 330). The 99.9th percentile of exposure for 
children 1 to 6 years old (the most highly exposed population subgroup) 
was estimated to be 0.008328 mg/kg/day (MOE of 120). Therefore, FMC 
concludes that the acute dietary risk of bifenthrin, as estimated by 
the dietary risk assessment, does not appear to be of concern.
    b. Chronic exposure and risk. The acceptable RfD is based on a 
NOAEL of 1.5 mg/kg/day from the chronic dog study and an uncertainty 
factor 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 0.000165 
mg/kg body weight (bwt)/day and utilize 1.1% of the RfD for the overall 
U.S. population. Children 1-6 years old (subgroups most highly exposed) 
is estimated to be 0.000342 mg/kg bwt/day and utilizes 2.3% of the RfD. 
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 
concludes that the chronic dietary risk of bifenthrin, as estimated by 
the dietary risk

[[Page 20814]]

assessment, does not appear to be of concern.
    ii. Drinking water. Laboratory and field data have demonstrated 
that bifenthrin is immobile in soil and will not leach into ground 
water. Other data show that bifenthrin is virtually insoluble in water 
and extremely lipophilic. As a result, FMC 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 
ground water 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 analyses, the 
contribution of water to the dietary risk estimate is negligible. 
Therefore, FMC concludes that together these data indicate that 
residues are not expected to occur in drinking water.
    2. Non-dietary exposure. Laboratory and field data have 
demonstrated that bifenthrin is immobile in soil and will not leach 
into ground water. Other data show that bifenthrin is virtually 
insoluble in water and extremely lipophilic. As a result, FMC 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 PRZM3. Based on this screening 
assessment, the potential concentrations of a pyrethroid in ground 
water at depths of 1 and 2 meters are essentially zero (<<0.001 parts 
per billion). Surface water concentrations for pyrethroids were 
estimated using PRZM3 and 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 analyses, the contribution of water to the dietary risk estimate 
is negligible. Therefore, FMC concludes that together these data 
indicate that residues are not expected to occur in drinking water.

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 intends to submit information 
for EPA to consider concerning potential cumulative effects of 
bifenthrin 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. For the overall U.S. population, the calculated 
MOE at the 95th percentile was estimated to be 619; 348 at the 99th 
percentile; and 176 at the 99.9th percentile. For all infants less than 
1 year old, the calculated MOE at the 95th percentile was estimated to 
be 532; 233 at the 99th percentile; and 169 at the 99.9th percentile. 
For nursing infants less than 1 year old, the calculated MOE at the 
95th percentile was estimated to be 1,309; 450 at the 99th percentile; 
and 240 at the 99.9th percentile. For non-nursing infants less than 1 
year old, the calculated MOE at the 95th percentile was estimated to be 
474; 181 at the 99th percentile; and 168 at the 99.9th percentile. For 
the most highly exposed population subgroup, children1-6 years old, the 
calculated MOE at the 95th percentile was estimated to be 320; 208 at 
the 99th percentile; and 100 at the 99.9th percentile. Therefore, FMC 
concludes that there is reasonable certainty that no harm will result 
from acute 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 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.
    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 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%.
    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. Prenatal and postnatal sensitivity--a.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.
    b. Postnatal. 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.
    v. Conclusion. Based on the above, FMC concludes that reliable data 
support use of the standard 100-fold uncertainty factor, and that an 
additional uncertainty factor is not

[[Page 20815]]

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 the 
residue of bifenthrin in or on leaf petioles.
[FR Doc. 01-10125 Filed 4-24-01 8:45 am]
BILLING CODE 6560-50-S