Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: October 20, 1999 (Volume 64, Number 202)]
[Notices]               
[Page 56502-56505]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc99-57]                         

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ENVIRONMENTAL PROTECTION AGENCY

[PF-895; FRL-6386-9]

 
Notice of Filing a Pesticide Petition 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 a pesticide 
petition 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-895, must be 
received on or before November 19, 1999.

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'' section. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
control number PF-895 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Indira Gairola, Minor Use 
Inert's, & Emergency Response Branch, Registration Division (7505C), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460; telephone number: (703) 308-6379; and 
e-mail address: gairola.indira@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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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-895. 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 Mall2, 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-895 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, 401 M St., SW., 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 Mall2, 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

[[Page 56503]]

submissions will be accepted in Wordperfect 5.1/6.1 or ASCII file 
format. All comments in electronic form must be identified by docket 
control number PF-895. 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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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 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: October 7, 1999.

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

 Monsanto Company

 PP 1E4031

    EPA has received a pesticide petition (PP 1E4031) from Monsanto 
Company, 700 14th St., NW., (1100), Washington, DC 20005 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 3-dichloroacetyl-5-(2-furanyl)-2,2-
dimethyloxazolidine (furilazole in or on the raw agricultural commodity 
(RAC) field corn grain, forage, and fodder at < 0.01 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 supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism in corn was studied with 
radiolabeled furalizole in the green house and the field. Parent 
furilazole was not found in any of the corn samples. Furilazole is 
rapidly and extensively metabolized to a large number of highly polar 
metabolites characterized as weak organic acids or residues conjugated 
to natural sugars. No parent furilazole was found in the plants at all.
    2. Analytical method. Monsanto has developed an analytical method 
using gas liquid chromatography with electron capture detection that 
has a verified limit of quantitation (LOQ) of 0.01 ppm for parent MON 
13,900 in corn grain, forage, and fodder. This method has been 
validated by the Agency.
    3. Magnitude of residues. Monsanto has conducted five residue field 
studies with furilazole applied pre-emergence to corn at rates up to 
0.75 pound per acre. Analysis of corn forage, silage, fodder, and grain 
showed no residues with an analytical method that is validated at the 
lower limit of 0.01 ppm. Three residue field studies with furilazole 
applied pre-emergence to corn at exaggerated rates up to 26 times the 
proposed maximum use rate showed no measurable residues (< 0.01 ppm) in 
corn grain. Based on these results, it was concluded that the potential 
for measurable concentration of furilazole in processed commodities of 
corn was very low and that processing studies were not required.

B. Toxicological Profile

    1. Acute toxicity--i. An acute oral toxicity study in the rat with 
an LD<INF>50</INF> of 869 mg/kg. Toxicity Category III.
    ii. An acute dermal toxicity study in the rabbit with an 
LD<INF>50</INF> of > 5,000 mg/kg. Toxicity Category IV.
    iii. An acute inhalation study in the rat with a 4-hour inhalation 
LC<INF>50</INF> of 2.3 milligrams per liter (mg/L), the highest 
attainable concentration. Toxicity Category III.
    iv. A rabbit eye irritation study in which furilazole is determined 
to be a mild eye irritant. Toxicity Category III.
    v. A rabbit primary dermal irritation study indicating that 
furilazole is a negligible dermal irritant. Toxicity Category IV.
    vi. A dermal sensitization study in guinea pigs indicating that 
furilazole does not produce delayed contact hypersensitivity.
    2. Genotoxicty. Mutagenicity studies including in vivo/in vitro 
unscheduled DNA synthesis (UDS) in rat hepatocytes, gene mutation in 
cultured Chinese hamster ovary cells (CHO/HGPRT), and

[[Page 56504]]

in vivo micronucleus assay were negative. A Salmonella typhimurium/
mammalian microsome mutagenicity assay, with and without metabolic 
activation, indicated that furilazole induced a reproducible mutagenic 
response, but only at a high and precipitating dose.
    3. Reproductive and developmental toxicity--i. A rat developmental 
effects study with a no observed adverse effect level (NOAEL) for 
maternal toxicity of 10 milligrams/kilograms/day (mg/kg/day) and 
developmental toxicity of 10 mg/kg/day.
    ii. A 2-generation reproduction study in rats fed diets containing 
0, 15, 150, and 1,500 ppm furilazole. The NOAEL for systemic toxicity 
was 150 ppm (9 to 11 mg/kg/day) for both parents and offspring. There 
were no treatment-related effects on reproductive performance or 
offspring survival at any dose level; therefore, the NOAEL for 
reproductive toxicity was 1,500 ppm or 101 mg/kg/day.
    4. Subchronic toxicity--i. A 90-day oral toxicity study in the rat 
with a NOAEL of 100 ppm, or 7 mg/kg/day.
    ii. A 90-day oral toxicity study in the dog with a NOAEL of 15 mg/
kg/day.
    iii. A 21-day repeated dose dermal toxicity study in rats with a 
NOAEL > 1,000 mg/kg/day.
    5. Chronic toxicity. A 24-month chronic feeding and oncogenicity 
study in the rat at doses of 0, 5, 100, 1,000, and 2,000 (females)/
2,500 (males) ppm. The liver, stomach, and testes were the main target 
organs. Oncogenic effects were seen in the stomach and liver of females 
and in the stomach, liver, and testes of males. The NOAEL for oncogenic 
effects was 100 ppm (5.05 mg/kg/day for males and 6.03 mg/kg/day for 
females). The NOAEL for chronic toxicity was 5 ppm (0.26 mg/kg/day for 
males) and 100 ppm ( 6.03 mg/kg/day for females). An 18-month 
oncogenicity study in mice fed doses of 0, 5, 40, 400, 1,250, and 2,500 
(males)/3,500 (females) ppm. The liver and the lung were the target 
organs. Oncogenic effects were observed in livers and lungs of both 
sexes. The NOAEL for chronic toxicity and for oncogenic effects was 40 
ppm (5.93 mg/kg/day in males) and 400 ppm (92.0 mg/kg/day in females).
    6. Animal metabolism. Because field trial residue data showed non-
detectable residues of furilazole in corn, neither animal metabolism 
nor residue transfer studies with livestock were required. It is 
considered likely that metabolism will be similar to that of other 
dichloroacetamide safeners in mammals which are characterized by 
extensive metabolism and elimination of most of the residue from the 
body with very low levels of parent safener, if any, retained in the 
tissues. The major route of metabolism is typically glutathione 
conjugation followed by formation of an aldehyde intermediate which is 
then either oxidized to an oxamic acid or reduced to the corresponding 
alcohol.
    7. Metabolite toxicology. The metabolism of furilazole is extensive 
and results in a large number of polar metabolites each of which is 
present in soil or corn plants in very low concentrations. These 
metabolites have not been identified as being of toxic concern.
    Based on the available toxicity data, Monsanto believes the 
reference dose (RfD) for furilazole should be based on the NOAEL 
observed in the chronic rat study, 0.26 mg/kg/day for males or 6 mg/kg/
day for females. Using an uncertainty factor of 100, the RfD would be 
0.0026 mg/kg/day. For cancer risk assessment for furilazole, Monsanto 
believes that margin of exposure (MOE) assessment should be calculated 
using the oncogenic NOAEL of 5 mg/kg/day observed in the rat, which was 
the most sensitive species.

C. Aggregate Exposure

    1. Food. Monsanto has used the Theoretical Maximum Residue 
Contribution (TMRC) as a conservative estimate of the potential dietary 
exposure for furilazole. This approach assumes that 100% of all RAC for 
which tolerances have been established for acetochlor, bear tolerance-
level (0.01 ppm) residues of furilazole. This over-estimate of actual 
dietary exposure provides a quite conservative basis for risk 
assessment.
    i. Drinking water. Furilazole is photolyzed rapidy with half-lives 
of 8 hours in water in the presence of humic acid, and 8 to 9 days in 
soil. The aerobic soil half-life is approximately 5 to 8 weeks. 
Furilazole is stable to hydrolysis, but its metabolites that have 
modifications to the dichloroacetyl group are susceptible to hydrolyis 
as a further step in degradation. In terrestrial field dissipation 
studies conducted with application rates of 0.75 to 0.8 pounds per acre 
in eight sites with a range of soil types, furilazole dissipated 
readily with an average DT<INF>50</INF> of about 13 days. This low 
persistence in the environment combined with the low application rate 
(maximum of 0.4 pound per acre) indicates that furilazole is not likely 
to be present in ground water. Based on these considerations, Monsanto 
does not anticipate exposure to residues of furilazole in drinking 
water. EPA has not established a Maximum Concentration Level (MCL) or a 
health advisory level for residues of furilazole in drinking water.
    2. Non-dietary exposure. Furilazole is used only as a safener or 
antidote to the effects of acetochlor herbicide on corn seed or 
seedlings. It is sold only as part of acetochlor herbicide end-use 
products which are classified as Restricted Use by EPA which means they 
are used only by certified applicators and are not available to the 
general public. Herbicide products containing furilazole are not 
registered for residential, home owner, or other non-crop uses. They 
are thus not used in parks, school grounds, public buildings, roadsides 
or rights-of-way or other public areas. Commercial cornfields are 
generally located well away from public areas where incidental contact 
could occur. Therefore, the general public is very unlikely to have any 
non-dietary exposure to furilazole.

D. Cumulative Effects

    Monsanto has no reliable data or information to suggest that 
furilazole has toxic effects that arise from toxic mechanisms that are 
common to other substances. Therefore, a consideration of common toxic 
mechanism and cumulative effects with other substances is not 
appropriate for furilazole, and Monsanto is considering only the 
potential effects of furilazole in this aggregate exposure assessment.

E. Safety Determination

    1. U.S. population--i. Chronic risk. The conservative estimate of 
aggregate chronic exposure is 3.0 x 10<SUP>-6</SUP> mg/kg/day. This 
potential exposure represents only 0.12% of the RfD of 0.0026 mg/kg/day 
and provides a MOE of 1,666,667 when compared to the 5 mg/kg/day 
carcinogenic reference point. EPA generally has no concern for 
exposures below 100% of the RfD and there are adequate margins of 
safety for cancer. Monsanto concludes there is a reasonable certainty 
of no harm resulting from exposure to furilazole.
    2. Infants and children. Employing the same conservative TMRC 
estimates of exposure used in the risk assessment for the general 
population, Monsanto has calculated that the aggregate exposures for 
nursing infants, non-nursing infants, children age 1-6 and children age 
7-12 are less than 0.4% of the RfD for each group. EPA generally has no 
concern for exposures below 100% of the RfD.
    Monsanto notes the developmental toxicity NOAEL for rats (10 mg/kg/
day) is 38.5-fold higher than the NOAEL of 0.26 mg/kg/day in the 
chronic rat study on which the RfD is based. This

[[Page 56505]]

indicates that the RfD is adequate for assessing risk to children. 
Also, the developmental toxicity NOAEL of 10 mg/kg/day is the same as 
the NOAEL for maternal toxicity, indicating that offspring are not more 
sensitive than parents.
    In the 2-generation rat reproduction study, the NOAEL for 
reproductive toxicity and offspring survival was 101 mg/kg/day. This is 
388-fold higher than the NOAEL for chronic toxicity upon which the RfD 
is based. The NOAEL for pup toxicity was no higher than the NOAEL for 
parental toxicity, indicating there is no unique sensitivity for 
offspring to furilazole.
    Monsanto believes that these data do not indicate an increased 
prenatal or postnatal sensitivity of children and infants to furilazole 
exposure and concludes that the 100-fold uncertainty factor used in the 
RfD is adequate to protect infants and children.

F. International Tolerances

    The Codex Alimentarius Commission has not established a maximum 
residue level for furilazole.
[FR Doc. 99-27395 Filed 10-19-99; 8:45 am]
BILLING CODE 6560-50-F
Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food

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