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[Federal Register Volume 65, Number 15 (Monday, January 24, 2000)]
[Notices]
[Pages 3690-3693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1551]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-914; FRL-6486-8]

Notice of Filing Pesticide Petitions to Establish a Tolerance for 
Certain Pesticide Chemicals 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 
certain pesticide chemicals in or on various food commodities.

DATES:  Comments, identified by docket control number PF-914, must be 
received on or before February 23, 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-914 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Mary Waller, Registration 
Support Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 
308-9354; 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
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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-914. 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.,

[[Page 3691]]

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-914 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, Ariel Rios Bldg., 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-914. 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 certain 
pesticide chemicals 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 contain data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports 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 7, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them in any way. The petition 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.

AgrEvo USA Company

PP 6F4693; 4F4380

    EPA has received pesticide petitions (PP 6F4693, PP 4F4380) from 
AgrEvo USA Company, 2711 Centerville Road, Wilmington, DE 19808 
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 tolerances for residues of flutolanil in or on the raw 
agricultural commodities potatoes at 0.20 parts per million (ppm), and 
potato waste (wet) at 0.40 ppm, rice at 2.0 ppm, rice straw at 12.0 
ppm, and in or on the processed food commodities rice hulls at 7.0 ppm 
and rice bran at 3.0 ppm. EPA has determined that the petitions contain 
data or information regarding the elements set forth in section 
408(d)(2) of the FFDCA; however, EPA has not fully evaluated the 
sufficiency of the submitted data at this time or whether the data 
supports granting of the petitions. Additional data may be needed 
before EPA rules on the petitions.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of flutolanil in plants is 
adequately understood for the purposes of this petition. Plant 
metabolism studies have been conducted in rice, cucumber, and peanuts. 
The metabolic profile for flutolanil was similar in all three crops. 
The major route of degradation was 4'-O-dealkylation to 
desisopropylflutolanil, followed by conjugation. Other metabolites may 
occur at very low levels due to hydroxylation and oxidation of the side 
chain, hydroxylation of the aniline ring, and methylation of the 
hydroxyl groups. These minor metabolites were also subject to 
conjugation. The residues of concern are the parent, flutolanil, and 
desisopropylflutolanil.
    2. Analytical method. The analytical method designated AU-95R-04 
has been independently validated and is adequate for enforcement 
purposes. A multi-residue method for flutolanil has been previously 
submitted to the EPA. The method is for use only by

[[Page 3692]]

experienced chemists who have demonstrated knowledge of the principles 
of trace organic analysis and have proven skills and abilities to run a 
complex residue analytical method, obtaining accurate results at the 
part per billion level. Users of this method are expected to perform 
additional method validation prior to using the method for either 
monitoring or enforcement. The method can detect gross misuse.
    3. Magnitude of residues. Fourteen residue trials were conducted to 
determine the residues of flutolanil in potatoes after use as a seed 
piece protectant. Potato seed pieces were treated with flutolanil, 
planted, and the harvested potatoes analyzed for residues of 
flutolanil. In these studies, flutolanil-derived residues ranged from 
non-detectable ( 0.05 ppm) to 0.11 ppm in potato tubers.
    A processing study was also conducted to support the use of 
flutolanil as a potato seed piece protectant. Concentration of residues 
was observed into wet peel (1.7x). No concentration was observed in 
potato granules, chips, or flakes.

B. Toxicological Profile

    1. Acute toxicity. A battery of acute studies was conducted 
indicating an acute oral lethal dose\50\ (LD\50\) of > 10,000 
milligrams/kilograms (mg/kg) for rats and mice; an acute rat dermal 
LD\50\ of > 2,000 mg/kg; an acute rat inhalation LC\50\ of > 5.98 mg/L; 
no dermal irritation; slight eye irritation; and no evidence of dermal 
sensitization.
    2. Genotoxicity. Flutolanil has been tested in a battery of in 
vitro and in vivo assays. No evidence of genotoxicity was noted in gene 
mutation assays with Salmonella, E. coli or mouse lymphoma cells; a 
mouse micronucleus assay, or in an in vitro unscheduled DNA synthesis 
assay. A weakly positive response was noted in an in vitro cytogenetics 
assay in Chinese hamster lung cells but no evidence of clastogenicity 
was noted in an in vitro cytogenetics assay in human lymphocytes. The 
overall weight of evidence indicates that flutolanil is not genotoxic.
    3. Reproductive and developmental toxicity. A 3-generation rat 
reproduction study was conducted at dietary concentrations of 0, 1,000 
and 10,000 ppm. The no observed adverse effect level (NOAEL) for this 
study is considered to be 1,000 ppm (equivalent to 63 mg/kg/day), based 
on reduced pup weights late in lactation at 10,000 ppm. Because the 
Agency considered this study supplementary, a 2-generation rat 
reproduction study was subsequently conducted at dietary concentrations 
of 200, 2,000 and 20,000 ppm (equivalent to 1,936 mg/kg/day). The 
Agency, however, has concluded that the NOAEL of the original study (63 
mg/kg/day) should continue to be used for risk assessment.
    4. Subchronic toxicity. A 90-day rat feeding study was conducted at 
dose levels of 500, 4,000 and 20,000 ppm. The NOAEL in this study was 
considered to be 500 ppm (equivalent to 37 mg/kg/day for males and 44 
mg/kg/day for females) based on increased liver weights at 4,000 ppm 
and slightly decreased body weights at 20,000 ppm.
    5. Chronic toxicity. In a 2-year chronic toxicity/oncogenicity 
study, flutolanil was administered to rats at dietary levels of 0, 40, 
200, 2,000 and 10,000 ppm. The NOAEL was considered to be 2,000 ppm 
(86.9 mg/kg/day for males and 103.1 mg/kg/day for females) based on 
reduced body weight gain in males and increased liver weights in 
females at 10,000 ppm. No evidence of carcinogenicity was observed.
    6. Animal metabolism. Studies in rats, ruminants and poultry 
suggest that flutolanil is not well-absorbed following oral 
administration. Once absorbed, however, it is rapidly metabolized, 
primarily to desisopropylflutolanil and its conjugates, and rapidly 
excreted via urine and feces.
    7. Endocrine effects. No special studies have been conducted to 
investigate the potential of flutolanil to induce estrogenic or other 
endocrine effects. However, no evidence of such effects has been 
observed in the subchronic, chronic or reproductive studies previously 
discussed. Thus, the potential for flutolanil to cause endocrine 
effects is considered to be minimal.
    8. Toxicity endpoint selection. Flutolanil is of low acute toxicity 
via all routes of administration and did not induce significant 
maternal or developmental toxicity in either rats or rabbits, even at 
the limit dose of 1,000 mg/kg/day. Furthermore, no evidence of toxicity 
was noted following repeated dosing at 1,000 mg/kg/day in a 21-day 
dermal toxicity study.
    Thus, acute dietary, occupational and residential risk assessments 
are not considered necessary. The Agency has concluded that the chronic 
Referene Dose (RfD) for flutolanil should be 0.63 mg/kg/day, based on 
the NOAEL of 63 mg/kg/day from the first rat multigeneration 
reproduction study and a 100-fold Uncertainty Factor. The Agency has 
also determined that the carcinogenicity classification for flutolanil 
should be ``Group E--Evidence of Non-Carcinogenicity for Humans.''

C. Aggregate Exposure

    1. Dietary exposure. Flutolanil is registered for use on rice, 
peanuts, and turf and ornamentals. Registration for use on potatoes as 
a seed piece treatment has been proposed. Potential sources of non-
occupational exposure would consist of any potential residues in food 
and drinking water, and from uses of flutolanil on residential turf or 
ornamentals. As previously indicated, in the absence of any acute 
toxicity concerns, only chronic exposures have been evaluated.
    i. Food. Time-limited tolerances have been previously established 
for flutolanil in/on rice commodities, and tolerances with no time 
limitations are established for peanut commodities, meat, milk, and 
eggs. Tolerances have been proposed for flutolanil on potatoes. 
Potential dietary exposures to flutolanil from these food commodities 
were assessed using the Exposure 1 software system (TAS, 
Inc.) and food consumption data from the 1977-1978 USDA Continuing 
Surveys of Food Consumption by Individuals (CSFII). For the purposes of 
this assessment, it was assumed that 100% of all of the above 
commodities contained residues of flutolanil at the existing or 
proposed tolerance levels.
    ii. Drinking water. The potential for flutolanil to leach into 
ground water has been assessed in two terrestrial field dissipation 
studies, a long-term terrestrial field dissipation study, and an 
aquatic field dissipation study. Under field conditions, the half-life 
of flutolanil varied from 101 to 123 days in the long-term field soil 
dissipation study, which was consistent with the other field studies, 
and was approximately 180 days in the aquatic environment. Flutolanil 
strongly adsorbs to soil following application and did not exhibit 
mobility under either terrestrial or aquatic conditions. The water 
solubility of flutolanil is quite low (equivalent to 5.0 ppm). Based on 
these environmental fate data and the conditions of use, the potential 
for movement of flutolanil into ground water is very low, and as such 
the potential contribution of any such residues to the total dietary 
intake of flutolanil will be negligible. No Maximum Contaminant Level 
or Health Advisory Level for residues of flutolanil in drinking water 
has been established.
    2. Non-dietary exposure. As a professional use turf and ornamental 
fungicide, flutolanil is used primarily (> 95%) on golf courses for 
control of brown patch disease (Rhizoctonia solani). Very limited use 
of flutolanil may occur on commercial ornamental

[[Page 3693]]

turf by professional lawn care applicators or on sod farms. The product 
is rarely, if ever, used on homeowner turf due to the fact that the 
diseases it controls (Brown patch, Fairy ring, and snow molds) occur in 
high-fertility, high-maintenance turf (e.g., golf courses), not in 
homeowner lawns. Thus, non-dietary exposure to flutolanil would be 
minimal. Furthermore, no dermal toxicity endpoints of concern have been 
identified for flutolanil. Thus, an assessment of non-dietary exposure 
and risk is not considered to be necessary.

D. Cumulative Effects

    Flutolanil has demonstrated only minimal toxicity in animal 
studies. The mechanism of this toxicity is unknown. Furthermore, there 
are no available data to indicate that flutolanil has a common 
mechanism of toxicity with other substances. Thus, only the potential 
risks from flutolanil are being considered in this document.

E. Safety Determination

    1. U.S. population. Based on the existing and proposed tolerances 
in potatoes, rice, peanuts and, secondary commodities, the Theoretical 
Maximum Residue Contribution (TMRC) of the current action is estimated 
to be 0.001353 mg/kg/day for the U.S. population in general. This 
exposure would utilize less than 1% of the RfD. There is generally no 
concern for exposures below 100% of the RfD since the RfD represents 
the exposure level at or below which daily exposure over a lifetime 
will not pose any appreciable risks to human health. Therefore, there 
is a reasonable certainty that no harm will result in the U.S. 
population in general from aggregate exposure to flutolanil.
    2. Infants and children. Data from reproductive and developmental 
toxicity studies are generally used to assess the potential for 
increased sensitivity of infants and children. No evidence of 
developmental toxicity was noted in rats or rabbits, even at the limit 
dose of 1,000 mg/kg/day. Reduced pup weights in the absence of parental 
toxicity were noted at the high-dose level (10,000 ppm) in a 3-
generation rat reproduction study. However, no such effects were noted 
in a subsequent reproduction study, even at a higher dose level (20,000 
ppm). Furthermore, the reduced weight gain in the first study began 
late in the lactation period, at a time when the pups were likely 
ingesting significant quantities of diet. Feed intake is much higher in 
young animals than in adults and the apparent increase in sensitivity 
may simply reflect the higher test material intake in these pups on a 
mg/kg basis compared to the adults. Thus, AgrEvo believes that the 
overall weight of evidence does not indicate any special concern for 
infants and children, and that no additional safety factor is 
necessary.
    Based on the existing and proposed tolerances in rice, potatoes, 
peanuts, and secondary commodities, the TMRC from the current petition 
is estimated to be 0.006498 mg/kg/day for the most highly exposed 
subpopulation, non-nursing infants (less than 1 year old). This 
exposure would utilize approximately 1% of the RfD. Therefore, there is 
a reasonable certainty that no harm will result to infants or children 
from aggregate exposure to flutolanil.

F. International Tolerances

    No Codex Alimentarius Commission (CODEX) tolerances have been 
established for flutolanil.
[FR Doc. 00-1551 Filed 1-21-00; 8:45 am]
BILLING CODE 6560-50-F
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