[Federal Register Volume 66, Number 85 (Wednesday, May 2, 2001)]
[Notices]
[Pages 21971-21973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10809]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1017; FRL-6779-1]


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-1017, must be 
received on or before June 1. 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-1017 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration 
Support Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-9368; 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'' ``Regulation 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-1017. 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-1017 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-1017. 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

[[Page 21972]]

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 Cosmetic 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 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: April 18, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

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

Interregional Research Project Number 4 (IR-4)

PP 5E4557

    EPA has received a pesticide petition (5E4557) from Interregional 
Research Project #4 (IR-4), Center for Minor Crop Pest Management, 
Rutgers, The State University of New Jersey, 681 U.S. Highway #1 South, 
North Brunswick, NJ 08902-3390 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 a tolerance for residues of the 
fungicide dicloran, 2,6-dichloro-4-nitroaniline, in or on the raw 
agricultural commodity leafy greens subgroup (except spinach) at 10 
parts per million (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 
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 electron 
capture/gas liquid chromatography (EC GLC) is available for enforcement 
purposes. Parent compound is the only analyte in the tolerance 
expression.
    3.  Magnitude of residues. Existing tolerances for dicloran in 
lettuce and endive, which are also in Crop Subgroup 4-A, are supported 
by residue studies which have been previously reviewed by EPA. 
Tolerances for two other crops in Crop Group 4, celery and rhubarb, 
also exist. The existing data support the conclusion that residues of 
dicloran will not exceed 10 ppm for the leafy greens subgroup (except 
spinach).

B. Toxicological Profile

    1.  Acute toxicity. The acute oral lethal dose 50 (LD50) 
of technical dicloran is greater than 10,000 milligrams/kilogram (mg/
kg), the acute dermal LD50 is greater than 2,000 mg/kg, and 
the 4-hour acute inhalation lethal concentration 50 (LC50) 
is greater than 2 mg/liter. 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, carcinogenic and developmental 
studies, however, Gowan Company 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) was 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.
    In a 2-generation rat reproduction study, the NOAEL for systemic 
toxicity was 250 ppm (21 mg/kg/day) on the basis of reduced body weight 
gain and increased liver and kidney weights. The

[[Page 21973]]

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 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. In an 80-week mouse study, 
dicloran was not carcinogenic when administered at dose levels up to 
600 ppm (103 mg/kg/day). Hepatotoxicity indicated this to be the 
approximate maximum tolerated dose (MTD). In a 2-year rat study, 
dicloran was not carcinogenic when administered at 1,000 ppm (59 mg/kg/
day for males and 71 mg/kg/day for females).
    6. Animal metabolism. Dicloran is rapidly metabolized and excreted 
by rats, goats and hens. Numerous metabolites derived by reduction, 
acetylation, hydroxylation, deamination and dechlorination were 
observed.
    7. 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. Food. Novigen Sciences' DEEM version 7.62 
software was used to perform a worst-case analysis of the proposed 
action. In a theoretical maximum residue concentration (TMRC) analysis 
it was assumed that dicloran is used on 100% of the acreage of the 
currently registered crops, lettuce and endive, and that residues on 
these crops are equal to the tolerance levels. These assumptions were 
then applied to all of the crops in the leafy greens subgroup (except 
spinach), and the two cases were compared. It was found that the 
proposed tolerance for the leafy greens subgroup (except spinach) would 
increase the presumed exposure from 9.7% of the RfD to 9.9% for the 
general population. In the presumably most heavily exposed population 
subgroup, nursing females, exposure would increase from 11.8% to 11.9% 
of the RfD. Presumed exposure for children ages 1-6 would increase from 
7.5% to 7.9%, and the presumed exposure for children ages 7-12 would 
increase from 9.0% to 9.2% of the RfD. The presumed exposure of infants 
was no more than 0.2% of the RfD for any scenario.
    No developmental or reproductive effects have been observed which 
indicate special perinatal sensitivity. Therefore, an analysis of acute 
exposure has not been conducted.
    ii. Drinking water. Dicloran has no aquatic uses. 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, Gowan Company believes that chronic exposure 
from this source is very small.
    2. Non-dietary exposure. Dicloran has no aquatic, lawn, turf 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, Gowan Company is considering only the potential 
risks of dicloran in its aggregate exposure.

E. Safety Determination

    1. U.S. population. In the TMRC analysis described in section C 
above, it was concluded that the proposed action would increase the 
chronic dietary exposure to dicloran by no more than 0.2% of the RfD 
for the general population. Exposure from drinking water and all other 
routes is expected to be negligible. In the TMRC analysis described in 
section C above, it was concluded that the proposed action would 
increase the chronic dietary exposure to dicloran by no more than 0.2% 
of the RfD for the general population. Exposure from drinking water and 
all other routes is expected to be negligible.
    2. Infants and children. It was concluded that the proposed action 
would increase the chronic dietary exposure of infants by no more than 
0.1% of the RfD, of children ages 1-6 by no more than 0.4%, and of 
children ages 7-12 by no more than 0.2%.
    In assessing the potential for additional sensitivity of infants 
and children to residues of dicloran, EPA considers 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 developmental 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. Gowan 
Company concluded that there is a reasonable certainty of no harm to 
infants and children from aggregate exposure to dicloran residues.

F. International Tolerances

    Codex and Canadian maximum residue levels of 10 ppm, identical to 
the U.S. tolerance level, have been established for lettuce, which is 
the major crop in this crop subgroup. Dicloran is not registered on a 
leafy vegetable in Mexico.

[FR Doc. 01-10809 Filed 5-1-01; 8:45 am]
BILLING CODE 6560-50-S