[Federal Register Volume 64, Number 202 (Wednesday, October 20, 1999)]
[Notices]
[Pages 56502-56505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27395]
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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
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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="">50 of 869 mg/kg. Toxicity Category III.
ii. An acute dermal toxicity study in the rabbit with an
LD50 of > 5,000 mg/kg. Toxicity Category IV.
iii. An acute inhalation study in the rat with a 4-hour inhalation
LC50 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
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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 DT50 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 10-6 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
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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
