flutolanil (Moncoat) Pesticide Petition Filing 1/00
[Federal Register: January 24, 2000 (Volume 65, Number 15)]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
Notice of Filing Pesticide Petitions to Establish a Tolerance for
Certain Pesticide Chemicals in or on Food
AGENCY: Environmental Protection Agency (EPA).
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
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@example.com.
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:
Categories NAICS codes potentially
Industry 111 Crop production
112 Animal production
311 Food 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
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.,
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
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: ``firstname.lastname@example.org ,'' 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
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
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
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
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
Dated: January 7, 2000.
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
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
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
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
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
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