[Federal Register Volume 66, Number 11 (Wednesday, January 17, 2001)]
[Notices]
[Pages 4014-4017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1352]


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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: [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            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: ``[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-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