[Federal Register Volume 66, Number 220 (Wednesday, November 14, 2001)]
[Notices]
[Pages 57079-57082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28524]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1055; FRL-6809-7]


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-1055, must be 
received on or before December 14, 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-1055 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis McNeilly, Insecticide 
Rodenticide Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-6742; 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 homepage at http://www.epa.gov/. 
To access this document, on the homepage 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-1055. 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

[[Page 57080]]

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-1055 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-1055. 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: November 2, 2001.

Peter Caulkins,
Acting 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 views 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.

Bayer Corporation

1F6315

    EPA has received a pesticide petition (1F6315) from Bayer 
Corporation, 8400 Hawthorn Road, Kansas City, MO 64120 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 clothianidin 
in or on the raw agricultural commodity canola, seed; corn, grain; 
corn, fodder; corn, forage; meat and meat by-products, and milk at 
0.01, 0.01, 0.10, 0.10, 0.02, and 0.01 parts per million (ppm), 
respectively. 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. In plants, the metabolism of clothianidin is 
adequately understood for the purposes of establishing these proposed 
tolerances. Unchanged parent clothianidin was the predominant residue 
in all crop matrices (14.4% to 64.5% in corn, 66.1% to 96.6% in 
tomatoes, 4.3% to 24.4% in sugar beets, and 24.3% to 63.3% in apples), 
with the exception of sugar beet leaves. In sugar beet leaves, the main 
components were the methylguanidine and thiazolylmethylguanidine 
metabolites, accounting for 28.6% and 27.7%, respectively. All 
metabolites found in plants were also found in the animal metabolism 
studies. In animals, parent clothianidin was the major component in 
liver, muscle and fat. Based on the

[[Page 57081]]

available metabolism data, parent clothianidin, thiazolyl-guanidine 
(TZG), thiazolyl-urea (TZU), and aminothiazol methylguanidine-pyridine 
(ATMG-Pyr) are proposed to be considered as the residues of concern in 
livestock matrices.
    2. Analytical method. In plants and plant products, the residue of 
concern, parent clothianidin, can be determined using high performance 
liquid chromotography (HPLC) with Electrospray MS/MS detection. In an 
extraction efficency testing, the plant residues method has also 
demonstrated the ability to extract aged clothianidin residue.
    In anamial matrices, the residues parent clothianidin, TZG, TZU, 
and ATMG-Pyr can also be determined using HPLC with Electrospray MS/MS 
detection. In an extraction efficiency testing, the animal residues 
method has also demonstrated the ability to extract aged clothianidin, 
TZG, TZU, and ATMG-Pyr residues.
    Although the plant and animal residues LC-MS/MS method is highly 
suitable for enforcement method, an LC-UV method has also been 
developed which is suitable for enforcement (monitoring) purposes in 
all relevant matrices.
    3. Magnitude of residues-i. Corn. A total of 27 field trials were 
conducted to evaluate the quantity of clothianidin in field, pop, and 
sweet corn. Corn seed was treated with clothianidin at a rate of 2 mg 
active ingredient (a.i.)/seed. The highest average field trial was 0.06 
ppm in sweet corn forage with ears at 75 days pre-harvest interval 
(PHI), 0.03 ppm in late dough-stage corn forage at 85 days PHI, and 
0.05 ppm in corn fodder at 136 days PHI. All grain and sweet corn ear 
samples contained<0.01 ppm clothianidin residue. The corn processing 
study indicated no concentration in any corn processed-commodities 
following the proposed seed treatment use.
    ii. Canola. A total of 22 field trials was conducted to determine 
the residue level in canola following the planting of canola seed 
treated with clothianidin at a rate of 600 g a.i./100 kg seed. All 
canola seed samples contained <0.01 ppm clothianidin residue. The 
canola processing study indicated no concentration in any canola 
processed commodities following the proposed seed treatment use.

B. Toxicological Profile

    1. Acute toxicity. The acute oral LD50 was >5,000 
milligrams/kilograms/body weight (mg/kg bw) for both male and female 
rats. The acute dermal LD50 was greater than 2,000 mg/kg bw 
in rats. The 4-hour inhalation LC50 was 6.14 mg/L for male 
and female rats. Clothianidin was not irritating to rabbit skin or eyes 
and did not cause skin sensitization in guinea pigs.
    2. Genotoxicty. Extensive mutagenicity studies were conducted with 
clothianidin. Based on the weight of evidence, clothianidin was 
considered negative for genotoxicity.
    3. Reproductive and developmental toxicity. In a 2-generation 
reproduction study, rats were administered dietary levels of 0, 150, 
500, and 2,500 ppm. The no observed adverse effect level (NOAEL) for 
reproductive parameters was 2,500 ppm. The NOAEL for developmental 
effects was 500 ppm, based on decreased pup weights. The parental NOAEL 
was 150 ppm, based on the decreased body weights.
    A developmental toxicity study was conducted in rats with 
clothianidin using dose levels of 0, 10, 50, and 125 mg/kg bw by 
gavage. The NOAEL for maternal toxicity was established at 10 mg/kg bw 
and for developmental effects it was >125 mg/kg bw. Additionally, a 
developmental toxicity was conducted with rabbits treated orally by 
gavage at 0, 10, 25, 75, and 100 mg/kg bw. The NOAEL for maternal 
toxicity was 10 mg/kg bw and for developmental toxicity it was 75 mg/kg 
bw.
    Developmental toxicity studies showed no primary developmental 
toxicity and no teratogenic potential was evident.
    4. Subchronic toxicity. Ninety-day feeding studies were conducted 
in rats and dogs. The rat study was conducted at dietary levels of 0, 
150, 500, and 3,000 ppm, and the dog study was conducted at 0, 325, 
650, and 1,500 ppm. The NOAELs were established at 500 ppm for rat and 
650 ppm for the dog.
    5.Chronic toxicity. A 2-year combined rat chronic/oncogenicity 
conducted at dietary levels of 0, 150, 500, 1,500, and 3,000 ppm 
demonstrated a NOAEL of 150 ppm based on reduced weight gains and non-
neoplastic histomorphological changes. A 78-week mouse oncogenicity 
study conducted at dose levels of 0, 100, 350, 1,250, and 2,000, and 
1,800 ppm for males and females, respectively, revealed a NOAEL of 350 
ppm based on reduced body weight gains and increased incidence of 
hypercellular hypertrophy. No evidence of oncogenicity was seen in the 
rat or the mice. A 52-week chronic toxicity study in dogs conducted at 
dietary levels of 0, 325, 650, 1,500, and 2,000 ppm revealed an overall 
NOAEL of 325 ppm and NOAEL of 650 ppm based on slight decrease in 
alanine aminotransferase activity (ALT).
    6. Animal metabolism. The nature of the clothianidin residue in 
livestock is adequately understood. In animals, parent clothianidin was 
the major component in liver, muscle and fat. Based on the available 
metabolism data, parent clothianidin, TZG, TZU, and ATMG-Pyr are 
proposed to be considered as the residues of concern in livestock 
matrices.
    7. Metabolite toxicology. Eight in vivo metabolites of clothianidin 
identified in the rat were investigated for acute oral endpoint 
mutagenic activity. None of the metabolites were mutagenic either with 
or without activation, and the LD50 values range from <500 
to >2,000 mg/kg, showing low to moderate toxicity.
    8. Endocrine disruption. All guideline studies conducted to 
characterize toxicological profile showed no endocrine related toxicity 
or tumorgenicity. No effects on triiodothyronine (T3), throxine (T4) or 
thyroid stimulating hormone (TSH) were observed in the subchronic rat 
study. In a 2-generation reproduction study in the rat, rat and rabbit 
teratology studies clothianidin did not show reproductive or 
teratogenic effects. The extensive data base shows that clothianidin 
has no endocrine properties.

C. Aggregate Exposure

    1. Dietary exposure. The acute reference dose (aRfD) of 0.6 mg/kg 
bw/day (acute NOAEL with a uncertainty factor) was used to assess acute 
dietary exposure. Bayer has conducted an acute dietary exposure Tier 2 
assessment estimating the percent of the aRfD and corresponding margins 
of exposure (MOE) for the overall U.S. population (all seasons) and the 
following subpopulations: All infants (<1-year), non-nursing infants 
(<1-year), children (1-6 years), children (7-12 years), females (13-19 
years), females (13-50 years), males (13-19 years), males (>20 years), 
and seniors (>55 years). In this refined Tier 2 analysis, all evaluated 
population subgroups had an exposure equal to 0% of the aRfD with a 
corresponding MOE of >1,000,000 at the 95th percentile.
    The chronic reference dose (cRfD) of 0.097 mg/kg bw/day (chronic 
NOAEL with a 100-fold uncertainty factor) was used to assess chronic 
dietary exposure. Bayer's chronic dietary analysis estimated the 
percent of the cRfD and corresponding margins of exposure (MOE) for the 
overall U.S. population (all seasons) and the following subpopulations: 
All infants (<1-year), non-nursing infants (<1-year), children

[[Page 57082]]

(1-6 years), children (7-12 years), females (13-19 years), females (13-
50 years), males (13-19 years), males (>20 years), and seniors (>55 
years). In this analysis, all evaluated population subgroups had an 
exposure equal to 0% of the cRfD. The corresponding MOE was >1,000,000.
    i. Food. Since clothianidin is not currently registered, projected 
percent crop treated values were used for the chronic and acute dietary 
analyses.
    ii. Drinking water. For drinking water, the models SCI-GROW (ground 
water), and FIRST (surface water), were selected to calculate the 
potential exposure of clothianidin in drinking water. Each model 
generated an acute water concentration, and the higher of the two 
concentrations was selected to represent the acute exposure, and 
similarly for the chronic exposure. The acute environmental exposure 
was determined to be 3.24 g/L (from surface water), and the 
chronic environmental exposure was 0.724 g/L (from ground 
water). Both exposures result from clothianidin used as a seed 
treatment on corn. Based on the standard exposure scenarios for 
drinking water (70 kg adult - 2 L/day; 10 kg child - 1 L/day), the 
human exposure and risk can be estimated. Using the acute (0.60 mg/kg/
day) and chronic (0.097 mg/kg/day) RfDs, the human risk from exposure 
to clothianidin in drinking water was determined to be less than 0.03% 
of the RfD in adults, and less than 0.08% of the RfD in children (the 
maximum human exposure was 0.32 g/kg/day, for acute exposure 
for children).
    2. Non-dietary exposure. Clothianidin is currently not registered 
for use on any residential non-food site. Therefore, residential 
exposure to clothianidin residues will be through dietary exposure 
only.

D. Cumulative Effects

    There is no information available to indicate that toxic effects 
produced by clothianidin are cumulative with those of any other 
compound.

E. Safety Determination

    1. U.S. population. Using the conservative exposure assumptions 
described above and based on the completeness of the toxicity data, it 
can be concluded that total aggregate exposure to clothianidin from all 
proposed uses will equal to 0% of the RfD for the overall U.S. 
population. All evaluated population subgroups had an expousre equal to 
0% of the RfD. 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. Thus, it can be concluded that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to clothianidin residues.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of clothianidin, the 
data from developmental toxicity studies in both the rat and rabbit, a 
2-generation reproduction study in rats and a developmental 
neurotoxicity study in rats have been considered.
    The developmental toxicity studies evaluate potential adverse 
effects on the developing animal resulting from pesticide exposure of 
the mother during prenatal development. The reproduction study 
evaluates effects from exposure to the pesticide on the reproductive 
capability of mating animals through two generations, as well as any 
observed systemic toxicity.
    The developmental neurotoxicity studies evaluate the 
neurobehavioral and neurotoxic effects on the developing animal 
resulting from the exposure of the mother. FFDCA section 408 provides 
that EPA may apply an additional uncertainty factor for infants and 
children based on the threshold effects to account for prenatal and 
postnatal effects and the completeness of the toxicity data base. Based 
on the current toxicological data requirements the toxicology data base 
for clothianidin relative to prenatal and postnatal development is 
complete, including the developmental neurotoxicity study. None of the 
studies indicated the offsprings to be more sensitive. All effects were 
secondary to severe maternal toxicity. The RfD for clothianidin was 
calculated using the NOAEL of 9.7 mg/kg bw/day from the 2-year chronic/
oncogenicity study. This NOAEL is lower than the NOAEL from the 2-
generation reproduction study, the developmental studies, and the 
developmental neurotoxicity study. Moreover, using a toxicologically 
justified UF of 100, the RfD for a non-oncogenic clothiandin was 
established at a level 0.097 mg/kg/day, a value that offers a measure 
of safety that is still 1.7-fold higher than the highest RfD 
(imidacloprid at 0.057 mg/kg/day) of the 10 competitive compounds 
compared in this report.

F. International Tolerances

    No CODEX Maximum Residue Levels have been established for residues 
of clothianidin on any crops at this time.
[FR Doc. 01-28524 Filed 11-13-01; 8:45 am]
BILLING CODE 6560-50-S