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dicloran (Botran) Pesticide Petition Filing 1/01


ENVIRONMENTAL PROTECTION AGENCY


[PF-959; FRL-6599-5]



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-959, must be
received on or before February 16, 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-959 in the subject line on the first page of your
response.


FOR FURTHER INFORMATION CONTACT:  By mail: Mary Waller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9354; e-mail address: waller.mary@epa.gov.


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            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


[[Page 4015]]


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-959. 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-959 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: ``opp-docket@epa.gov,'' 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-959. 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 Comestic 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 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 2, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.


Summary of Petition


    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 method available to EPA for the
detection and measurement of the pesticide chemical residues or an
explanation of why no such method is needed.


Gowan Company


PP 7F4879


    EPA has received a pesticide petition (PP 7F4879) from Gowan
Company, P.O. Box 5569, Yuma, AZ 85366-5569 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 dicloran (2,6-dichloro-
4-nitroaniline) in or on the raw agricultural commodities peanuts at 3
parts per million (ppm), in peanut oil at 6 ppm. EPA received an
amendment for two additional tolerances. The existing tolerances for
dicloran on carrots is limited to residues resulting from post-harvest
use only and the existing tolerance for dicloran on tomatoes is


[[Page 4016]]


limited to residues from pre-harvest use only. Gowan has proposed to
expand the tolerances to permit residues resulting from pre-harvest use
on carrots and post-harvest use on tomatoes. No numerical change in the
current tolerance of 10 ppm on carrots and 5 ppm on tomatoes is
proposed. 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 dicloran in peaches, lettuce
and potatoes has been studied. Parent compound and numerous metabolites
derived by hydroxylation and acetylation of the nitro group, along with
deamination and hydroxylation of the amino group, were seen in all
crops. Glutathione conjugation with simultaneous removal of one or both
chlorine atoms was shown to occur.
    2. Analytical method. An adequate analytical method (EC GLC) is
available for enforcement purposes. Parent compound is the only analyte
in the tolerance expression.
    3. Magnitude of residues. Twenty-five residue trials were conducted
over 4 years. Average residues of 0.61 ppm were observed in peanuts and
the highest average residue observed was 2.85 ppm. An average
concentration factor of 1.6X in refined peanut oil was observed.
    Five pre-harvest and three combined pre-harvest plus post-harvest
carrot residue trials were conducted. Residues from the proposed pre-
harvest use pattern were in all cases well below the existing post-
harvest tolerance of 10 ppm.
    Post-harvest tomato residue studies were conducted. Variables
including dilution rates, application techniques and the composition
and concentration of various wax emulsions were investigated. It was
concluded that the proposed post-harvest use pattern will result in
residues which are below the existing tolerance of 5 ppm for pre-
harvest use.


B. Toxicological Profile


    1. Acute toxicity. The acute oral LD50 of technical
dicloran is greater than 10,000 milligrams/kilograms (mg/kg), the acute
dermal LD50 is greater than 2,000 mg/kg, and the 4-hour
acute inhalation LC50 is greater than 2 milligrams/liter
(mg/L). Dicloran is not a dermal irritant but is a sensitizer. Dicloran
is a mild eye irritant.
    2. Genotoxicity. The following genotoxicity tests were conducted:
gene mutation (Ames tests), structural chromosome aberration (in vivo
cytogenetic assay using human lymphocytes) and unscheduled DNA
synthesis using rat hepatocytes. Results were generally negative;
however, some Ames tests with the bacterium S. typhimurium showed a
positive response. Ames tests with E. coli were negative. In view of
the results of mammalian chronic, oncogenic and developmental studies,
however, it is considered that the results of the positive Ames tests
are not relevant to human toxicity.
    3. Reproductive and developmental toxicity. In a rabbit
developmental toxicity study, the maternal no observed adverse effect
level (NOAEL) was 8 mg/kg/day and the maternal lowest observed adverse
effect level (LOAEL) as 20 mg/kg/day. The developmental NOAEL was
greater than or equal to 50 mg/kg/day, the highest dose tested.
    In a rat developmental toxicity study, the maternal and embryotoxic
NOAEL was 100 mg/kg/day, and the maternal and embryotoxic LOAEL was 200
mg/kg/day. The teratological NOAEL was greater than or equal to 400 mg/
kg/day, the highest dose tested (HDT).
    In a 2-generation rat reproduction study, the NOAEL for systemic
toxicity was 250 ppm (21 mg/kg/day) on the basis of reduced bodyweight
gain and increased liver and kidney weights. The NOAEL for reproductive
and developmental toxicity was also 250 ppm on the basis of reduced pup
weights. No other reproductive or developmental parameters were
affected at any treatment level. The highest dose tested was 1,250 ppm
(110 mg/kg/day).
    4. Subchronic toxicity. In 90-day rat studies, the NOAEL was
determined to be 500 ppm in the diet (44 mg/kg/day), and the LOAEL was
based upon increased liver weights in both sexes and centrilobular
hepatocyte enlargement in males. Similar effects, as well as an
increase in blood cholesterol concentration, were observed in 90-day
mouse studies, and the NOAEL was 15 mg/kg/day.
    5. Chronic toxicity. EPA has established the reference dose (RfD)
for dicloran at 0.025 mg/kg/day. The RfD for dicloran is based on a 2-
year dog feeding study with a NOAEL of 2.5 mg/kg/day and an uncertainty
factor of 100. The effect of concern was increased liver weight and
histological changes in hepatocytes.
    6. Animal metabolism. Dicloran is rapidly excreted by rats, goats,
and hens. Numerous metabolites derived by reduction, acetylation,
hydroxylation, deamination and dechlorination were observed.
    7. Carcinogenicity. In an 80-week mouse study, dicloran was not
oncogenic when administered at dose levels up to 600 ppm (103 mg/kg/
day). Heptotoxicity indicated this to be the approximate maximum
tolerance dose. In a 2-year rat study, dicloran was not oncogenic when
administered at 1,000 ppm (59 mg/kg/day for males and 71 mg/kg/day for
females).
    8. Endocrine disruption. Developmental toxicity studies in rats and
rabbits and a reproduction study in rats gave no indication of any
effects on endocrine function related to development and reproduction.
Subchronic and chronic treatment did not induce any morphological
changes in endocrine organs and tissues.


C. Aggregate Exposure


    1. Dietary exposure-- i. Chronic exposure. In a theoretical maximum
residue concentration (TMRC) worse-case analysis, it was assumed that
dicloran is used on 100% of the acreage of all crops on which it is
registered, and that residues on these crops are equal to the tolerance
levels. It was calculated that the chronic dietary exposure to the
general U.S. population would be 0.0265 mg/kg/day, or 106% of the
chronic RfD. For non-nursing infants, the most highly exposed subgroup,
the chronic dietary exposure from all crops is calculated to be 409% of
the RfD.
    Actual dietary chronic exposure is known to be much lower. The U.S.
Department of Agriculture, the U.S. Food and Drug Administration, and
California have monitored residues of dicloran in foods, and tens of
thousands of analyses have been performed. These databases are readily
examined using the Agency's own dietary exposure software, DEEM. It is
concluded that the current actual chronic dietary exposure to dicloran
from all foods is less than 0.002 mg/kg/day (less than 8% of the RfD)
for non-nursing infants, the most highly exposed subgroup, and less
than 0.001 mg/kg/day (less than 4% of the RfD) for the general U.S.
population and all other subgroups.
    Novigen Sciences DEEM software was used to perform a theoretical
maximum residue concentration (TMRC) analysis for peanuts, carrots, and
tomatoes. Actual results of peanut and tomato processing studies with
dicloran were incorporated. Dietary exposure was calculated to be
equivalent to 24% of the RfD for the U.S. population, 14% for non-
nursing infants and 49% for


[[Page 4017]]


children 1-6, the most heavily-exposed population subgroup. Given these
assumptions, the total dietary exposure from all current and proposed
uses would be equivalent to no more than 28% of the RfD for the U.S.
population, 22% for non-nursing infants and 53% for children 1-6. These
levels of exposure are acceptable.
    ii. Acute exposure. No developmental or reproductive effects have
been observed which indicate special perinatal sensitivity. Therefore,
an analysis of acute exposure has not been conducted.
    a. Food. Dicloran is registered for use on apricots, snap beans,
carrots, celery, sweet cherries, cucumbers, endive, garlic, grapes,
lettuce, nectarines, onions, peaches, plums, potatoes, rhubarb, sweet
potatoes and tomatoes. (See 40 CFR 180.200 for specific tolerances.)
The metabolism of dicloran in plants and animals is adequately
understood for the purposes of these tolerances. There is a practical
analytical method for detecting and measuring levels of dicloran in or
on food with a limit of detection that allows monitoring of food with
residues at or above the levels set in this tolerance.
    b. Drinking water. Dicloran was not reported in the Agency's survey
of pesticides in ground water from 1971-1991, nor in the Agency's 1988-
1990 survey of pesticides in drinking water wells. The compound has not
been reported in surface water. A small scale prospective ground water
study suggests that the average residue in ground water is well below
0.001 ppm. The Agency has not conducted a detailed analysis of
potential exposure to dicloran via drinking water; however, it is
believed that chronic exposure from this source is very small.
    2. Non-dietary exposure. Dicloran has no aquatic, lawn or
residential uses.


D. Cumulative Effects


    At this time the Agency has not reviewed available information
concerning the potentially cumulative effects of dicloran and other
substances that may have a common mechanism of toxicity. For purposes
of this petition only, the Agency is considering only the potential
risks of dicloran in its aggregate exposure.


E. Safety Determination


    1. U.S. population--Chronic risk. If it is assumed that all crops
on which dicloran is registered are treated, and if all residues on
crops are assumed to be equal to the tolerance levels, then it can be
calculated that the theoretical maximum residue concentration (TMRC) is
equal to 106% of the RfD for the general U.S. population and 408% of
the RfD for non-nursing infants, the most highly exposed group.
    Actual chronic risk is known to be much lower. Using anticipated
residue concentrations, it was concluded that chronic dietary exposure
to dicloran will be no more than 28% of the RfD. Exposures from
drinking water and all other routes is expected to be negligible.
    2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of dicloran, EPA
considered data from developmental toxicity studies in the rat and
rabbit and reproduction studies 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.
    No teratological effects have been observed with dicloran. The
lowest embryotoxic NOAEL in these studies was 100 mg/kg/day, compared
to a chronic NOAEL of 2.5 mg/kg/day. There is no indication of special
perinatal sensitivity in the absence of maternal toxicity and thus no
suggestion of special sensitivity of infants and children. It is
concluded that there is a reasonable certainty of no harm to infants
and children from aggregate exposure to dicloran residues.


F. International Tolerances


    There are no Codex, Canadian or Mexican maximum residue levels for
dicloran in peanuts. Although no numerical revisions of existing
tolerance levels are proposed for carrots or tomatoes, it is noted that
Canadian MRL's of 5 ppm exist for both carrots and tomatoes. Codex
MRL's of 10 ppm for carrots and 0.5 ppm for tomatoes exist.
[FR Doc. 01-1352 Filed 1-16-01; 8:45 am]
BILLING CODE 6560-50-F