[Federal Register Volume 65, Number 173 (Wednesday, September 6, 2000)]
[Notices]
[Pages 54019-54022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22391]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-975; FRL-6743-6]


Notice of Filing Pesticide Petitions 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 pesticide 
petitions 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-975, must be 
received on or before October 6, 2000.

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-975 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Dani Daniel, Registration 
Support Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5409; 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-975. 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-975 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records

[[Page 54020]]

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-975. 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 pesticide petitions 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 Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that these petitions 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: August 25, 2000.

  Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

    The petitioner summary of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petitions was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summaries verbatim without 
editing them in any way. The petition summaries 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.

Novartis Crop Protection, Inc.

PP 9F5046 and PP 9F5051

    EPA has received amended pesticide petitions (PP 9F5046 and PP 
9F5051) from Novartis Crop Protection, Inc., P.O. Box 18300, 
Greensboro, NC 27419 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 the combined residues of thiamethoxam, 3-[(2-chloro-5-
thiazolyl) methyl] tetrahydro-5-methyl-N-nitro-4H-1, 3, 5-oxadiazin-4-
imine and its major metabolite CGA-322704 N-(2-chloro-thiazol-5-
ylmethyl)-N'-methyl-N''-nitro-guanidine which will be commonly referred 
to as thiamethoxam throughout the rest of this document in or on the 
raw agricultural commodity rapeseed (canola), tuberous and corm 
vegetables crop subgroup, barley grain, sorghum grain, sorghum forage, 
sorghum stover, wheat grain, wheat hay, wheat straw, and milk at 0.02 
parts per million (ppm); barley straw at 0.03 ppm; barley hay at 0.05 
ppm; cotton, undelinted seed at 0.10 ppm; cucurbit vegetables crop 
group, and pome fruit crop group at 0.20 ppm; fruiting vegetables crop 
group at 0.25 ppm; wheat forage at 0.50 ppm; tomato paste at 0.80 ppm; 
head and stem Brassica vegetables crop subgroup at 1.00 ppm; cotton gin 
byproducts at 1.50 ppm; leafy vegetables crop group, and leafy Brassica 
greens crop subgroup at 2.00 parts per million (ppm). In addition, meat 
of cattle, goats, horses, and sheep at 0.02 ppm and meat byproducts of 
cattle, goats, horses, and sheep at 0.02 ppm. EPA has determined that 
the petition contains data or information regarding the elements set 
forth in section 408(d)(2) of the FFDCA; however, EPA has not fully 
evaluated the sufficiency of the submitted data at this time or whether 
the data supports granting of the petition. Additional data may be 
needed before EPA rules on the petition.

A. Residue Chemistry

    The residue chemistry profile for thiamethoxam which supports these 
amended petitions for tolerances was previously published in the 
Federal Register of May 5, 1999 (64 FR 24153) (FRL-6072-7).

B. Toxicological Profile

    The toxicological profile for thiamethoxam which supports these 
amended petitions for tolerances was previously published in the 
Federal Register of May 5, 1999 (64 FR 24153).

[[Page 54021]]

C. Aggregate Exposure

    1. Dietary exposure.-- Food and drinking water. Chronic dietary 
exposure was estimated using a Tier I approach by inputting tolerance 
level residues into the dietary exposure evaluation model 
(DEEMTM) software. The Tier I assessment was partially 
refined by adjusting for projected percent crop-treated information, 
and was made using the United States Department of Agriculture (USDA) 
national food consumption survey, continuing survey of food intakes by 
individuals (CSFII) 1994-96. The maximum total exposure to the U.S. 
population (48 contiguous states, all seasons) was calculated to be 
4.1% of the reference dose (RfD) of 0.013 milligrams/kilograms (mg/kg) 
body weight/day (bwt/day). The maximum exposure to the most sensitive 
population subgroup, children (1-6 years) was 9.5% of the RfD. The 
inclusion of the maximum concentration (Cmax) of thiamethoxam in water, 
taken from the highest estimated concentration observed from the 
generic expected environmental concentration (GENEEC) and screening 
concentration in ground water (SCI GROW) models, led to a maximum 
chronic dietary exposure of 4.5% in the U.S. population and 10.0% in 
children (1-6 years old).
    Acute dietary exposure was calculated using a Tier III, 
probabilistic assessment. A distribution of residue data points was 
included for the typically non-blended commodities of vegetables 
(tuberous, fruiting, cucurbit, Brassica, and leafy), pome fruits, meat 
and milk, while the average field trial value was used for the 
typically blended commodities of grains (wheat, sorghum, and barley), 
seed oil (cotton and canola), apple juice and tomato paste and puree. 
The acute assessment used adjustment for percent of crop treated, and 
was made using the DEEM software with the Monte Carlo analysis and the 
CSFII 1994-96 food consumption survey. The margin of exposure (MOE) no 
observed adverse effect level ((NOAEL)/exposure) for the U.S. 
population (all seasons) at the 99.9th percentile of the 
exposure distribution was 4,995 using the NOAEL value of 15 mg/kg bwt/
day. At the 99.9th percentile, the MOE for the most 
sensitive population subgroup (non-nursing infants <1 year old) was 
1,012. Inclusion of the drinking water value to the acute assessment 
led to an MOE of 4,904 at the 99.9th percentile of the U.S. 
population, and 1,008 for the population subgroup non-nursing infants 
<1 year old. The results of these analyses show that there is 
reasonable certainty that no harm will result from exposure to dietary 
residues (including drinking water) of thiamethoxam.
    2. Non-dietary exposure. Novartis also requests registrations for 
the use of thiamethoxam on dogs, turf and ornamentals. Novartis has 
identified potential non-dietary exposures to toddlers for these uses. 
These exposures include the following scenarios: Incidental non-dietary 
ingestion of residues on lawns from hand-to-mouth transfer, ingestion 
of thiamethoxam treated grass, and incidental ingestion of pesticide 
residues on pets from hand-to-mouth transfer.
    According to current EPA policy, these exposures are considered to 
be short-term oral exposures. EPA does not expect incidental ingestion 
of pesticide residues on pets from hand-to-mouth transfer to occur 
during the same period as the exposures from the turf uses. Thus, 
Novartis considered these exposures in separate estimates of risk. 
According to current EPA policy, if an oral endpoint is needed for 
short-term risk assessment (for incorporation of food, water, or oral 
hand-to-mouth type exposures into an aggregate risk assessment), the 
acute oral endpoint (acute RfD = 15 mg/kg bwt/day) will be used to 
incorporate the oral component into aggregate risk. Short-term 
aggregate exposure is defined by EPA to be average food and water 
exposure (chronic exposure) plus residential exposure. The short-term 
risk estimates for the population subgroup children, 1 to 6 years old, 
is summarized below. This population subgroup was chosen because it has 
the highest chronic food exposure and because toddlers have the highest 
exposure from the residential uses. From the results below, Novartis 
concludes there is no concern associated with the aggregate exposure to 
thiamethoxam: Short-term aggregate exposure and risk including turf for 
children 1 to 6 years old; dietary exposure estimate including water is 
0.001296 mg/kg bwt/day; residential exposure from turf is calculated to 
be 0.00497 mg/kg bwt/day; total exposure equals 0.0063 mg/kg bwt/day; 
percent acute RfD consumed is 0.04%; short-term aggregate exposure and 
risk including pet use for children 1 to 6 years old; dietary exposure 
estimate including water is 0.001296 mg/kg bwt/day; predicted hand to 
mouth transfer is 0.0341 mg/kg bwt/day; total exposure equals 0.035 mg/
kg bwt/day; and the percent acute RfD consumed is 0.23%

D. Cumulative Effects

    The potential for cumulative effects of thiamethoxam and other 
substances that have a common mechanism of toxicity has also been 
considered. Thiamethoxam belongs to a new pesticide chemical class 
known as the neonicotinoids. There is no reliable information to 
indicate that toxic effects produced by thiamethoxam would be 
cumulative with those of any other chemical including another 
pesticide. Therefore, Novartis believes it is appropriate to consider 
only the potential risks of thiamethoxam in an aggregate risk 
assessment.

E. Safety Determination

    1. U.S. population. Using the chronic exposure assumptions and the 
proposed RfD described above, the aggregate exposure (including 
drinking water) to thiamethoxam to the U.S. population (48 contiguous 
states, all seasons) was calculated to be 4.5% of the reference dose of 
0.013 mg/kg bwt/day. Therefore, Novartis concludes that there is 
reasonable certainty that no harm will result from aggregate chronic 
exposure to thiamethoxam residues.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of thiamethoxam, data 
from developmental toxicity studies in the rat and rabbit and a 2-
generation reproduction study in the rat have been considered.
    In teratology studies, delayed fetal development was apparent only 
at maternally toxic doses of thiamethoxam in rats and rabbits. In 
rabbits, 150 mg/kg/day was clearly toxic to does, causing death, weight 
loss, reduced food consumption, and perineal or vaginal discharge. 
Developmental toxicity occurred secondary to maternal toxicity and 
consisted of reduced fetal body weights and an increase in minor 
skeletal anomalies or variations. Maternal toxicity was also noted at 
50 mg/kg/day, consisting of reduced body weight and food consumption 
and total resorptions in one female. There was no indication of 
developmental toxicity at 50 mg/kg/day.
    The NOAEL for maternal toxicity was 15 mg/kg/day and for 
developmental toxicity was 50 mg/kg/day in rabbits. In rats, 200 and 
750 mg/kg/day caused maternal toxicity, but developmental toxicity 
secondary to maternal toxicity was observed only at 750 mg/kg/day. The 
NOAEL for maternal toxicity was 30 mg/kg/day and for developmental 
toxicity was 200 mg/kg/day.
    In a rat multi-generation study, parental toxic effects were noted 
at 2,500 ppm (250 mg/kg/day) and 1,000 ppm (100 mg/kg/day). Offspring 
body weights were reduced in males and females at 2,500 ppm (250 mg/kg/
day) and in females (F1 only) at 1,000 ppm (100 mg/kg/day). The NOAEL 
for

[[Page 54022]]

systemic toxicity in adult males was 30 ppm (approximately 3 mg/kg/day, 
range = 1.3 - 4.3 mg/kg/day) and in adult females was 1,000 ppm 
(approximately 100 mg/kg/day, range = 59.3 - 219.6 mg/kg/day). The 
NOAEL for toxicity to offspring was 30 ppm (approximately 3 mg/kg/day, 
range = 1.3 - 6.4 mg/kg/day). These studies show no evidence that 
developing offspring are more sensitive to than adults to the effects 
of thiamethoxam.
    FFDCA section 408 provides that EPA may apply an additional safety 
factor for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
data base. Based on the current toxicological requirements, the data 
base for thiamethoxam relative to prenatal and postnatal effects for 
children is complete. Further, for thiamethoxam, the developmental 
studies showed no increased sensitivity in fetuses as compared to 
maternal animals following in utero exposures in rats and rabbits, and 
no increased sensitivity in pups as compared to the adults in the 
multi-generation reproductive toxicity study. Therefore, it is 
concluded that an additional uncertainty factor is not warranted to 
protect the health of infants and children and that an RfD of 0.013 mg/
kg/day is appropriate for assessing aggregate risk to infants and 
children of thiamethoxam.
    Assuming tolerance level residues and adjusting for the percent of 
crops treated, only 7.0% of the thiamethoxam chronic RfD is utilized in 
the population subgroup all infant (<1 year old). Therefore, based on 
the completeness and reliability of the toxicity data base, Novartis 
concludes that there is reasonable certainty that no harm will result 
to infants and children from aggregate exposure to thiamethoxam 
residues.

F. International Tolerances

    There are no Codex, Canadian, or Mexican maximum residue levels 
established for the combined residues of thiamethoxam on rapeseed 
(canola), fruiting vegetables, tomato paste, head and stem Brassica 
vegetables, leafy Brassica greens, cucurbit vegetables, leafy 
vegetables, tuberous, and corm vegetables, barley grain, barley hay, 
barley straw, cotton (undelinted seed), cotton gin byproducts, pome 
fruit, wheat grain, wheat forage, wheat straw, wheat hay, sorghum 
grain, sorghum forage, sorghum stover, meat, and meat byproducts of 
cattle, goats, horses, and sheep, and milk.
[FR Doc. 00-22391 Filed 9-5-00; 8:45 am]
BILLING CODE 6560-50-S