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Cyhalofop-butyl (DowAgro). April
25, 2001. Federal Register.
Petition to Establish Tolerances in or on rice
grain, rice hull, rice bran, and polished rice at 0.03 ppm for grain and 8.0
ppm for straw.
[Federal Register: April 25, 2001 (Volume 66, Number 80)]
[Notices]
[Page 20808-20811]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap01-51]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-1009; FRL-6774-7]
Notice of Filing a Pesticide Petition to Establish a Tolerance
fora 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-1009, must be
received on or before May 25, 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-1009 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne Miller, Registration
[[Page 20809]]
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-6224; e-mail address:
miller.joanne@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 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'' 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-1009. 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-1009 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-1009. 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 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
[[Page 20810]]
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.
April 9, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide 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.
Dow AgroSciences LLC
PP 0F6089
EPA has received a pesticide petition (0F6089) from Dow
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268
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 cyhalofop-butyl in or on the
raw agricultural commodity rice grain, rice hull, rice bran, and
polished rice at 0.03 parts per million (ppm) for grain and 8.0 ppm for
straw. 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 of cyhalofop-butyl in plants
(rice) is adequately understood for the purposes of this tolerance. A
rotational crop study showed no carryover of significant cyhalofop-
butyl related residues in representative test crops.
2. Analytical method. An analytical method has been developed and
validated to determine the residues of total cyhalofop and the diacid
metabolite in rice grain, straw and processed products. The method was
based on capillary gas chromatography with mass selective detection
(GC/MSD) indicating limits of detection (LOD) and quantitation (LOQ)
for each analyte at 0.005-0.006 µg/g and 0.01-0.02 µg/
g, respectively.
3. Magnitude of residues. Metabolism studies in livestock at
exaggerated doses of cyhalofop-butyl (nominal concentration equivalent
to 10 ppm in the diet) indicated that about 87-90% of the administered
dose was eliminated in the excreta. The low levels of residues (0.001-
0.08 ppm) in fat and edible tissues, milk or eggs demonstrate that
residues due to cyhalofop-butyl would not accumulate in the animals.
B. Toxicological Profile
1. Acute toxicity. The acute toxicity of cyhalofop-butyl is low.
The oral and dermal LD50s were greater than 5,000 milligram/
kilogram (mg/kg), and the inhalation LC50 was greater than 5
mg/L. In addition, cyhalofop-butyl induced only minimal ocular and
dermal irritation, and did not cause dermal sensitization.
2. Neurotoxicity. Cyhalofop-butyl has been shown to have no
neurotoxicologic potential based on acute and subchronic studies.
3. Genotoxicty. Genetic toxicity did not occur when cyhalofop-butyl
was tested in multiple in vivo and in vitro tests.
4. Reproductive and developmental toxicity. Cyhalofop-butyl did not
have any effects on reproductive parameters at dose levels that induced
treatment-related effects in parental rats. In addition, a teratogenic
potential for cyhalofop-butyl was not demonstrated in either rats or
rabbits at dose levels that induced maternal toxicity.
5. Subchronic and chronic toxicity, and oncogenicity. Cyhalofop-
butyl caused increases in liver and kidney weights, microscopic
hepatocellular hypertrophy, renal tubular microscopic effects, and
distended gallbladders when given at sufficiently high dose levels to
the appropriate species for 13 weeks. Similar increases in liver and
kidney weights, hepatocellular hypertrophy, and renal effects were also
observed in chronic toxicity studies in rodents. In addition, mice had
liver inflammation (microgranulomas). Chronic toxicity in dogs was
limited to decreased body weight and the occurrence of concretions in
the gallbladder.
Using the Guidelines for Carcinogen Risk Assessment published
September 24, 1986 (51 FR 33992), it is proposed that cyhalofop and
cyhalofop-butyl be classified as Group E for carcinogenicity (no
evidence of carcinogenicity) based on the results of carcinogenicity
studies in two species. Dow AgroSciences LLC believes that there was no
evidence of carcinogenicity in an 18-mouse feeding study and a 24-month
rat feeding study at all dosages tested.
6. Animal metabolism. Orally administered cyhalofop-butyl is
rapidly absorbed, metabolized and excreted in the rat and dog. Once
absorbed, cyhalofop-butyl is hydrolyzed to the acid metabolite
(cyhalofop) with no significant quantities of unchanged parent compound
present in the plasma, tissues or excreta.
7. Metabolite toxicology. Cyhalofop-butyl is rapidly hydrolyzed
from the butyl ester to the acid in plants and the environment. Rats
and dogs have also been shown to rapidly hydrolyze the ester to the
acid. Mammalian toxicity studies that will test specifically the acid
(cyhalofop) in animals are not necessary since the animals in the
toxicity studies with the butyl ester have already been exposed to
large quantities of the acid. Plant metabolism studies have shown the
diacid to be the major metabolite thus analyzed in the samples from
crop field trials. This metabolite is more polar and less lipid soluble
than the acid and, therefore, would be expected to be less toxic than
the acid. Processing of the harvested crop does not result in any
residues that are not formed in animals, so additional toxicity studies
on residues are not required.
8. Endocrine disruption. There is no evidence from any of the
studies to suggest that cyhalofop-butyl is an endocrine disrupter.
C. Aggregate Exposure
Based on the rapid degradation of cyhalofop-butyl and its high
tendency to sorb to soils, no surface water or ground water
contamination is expected. This agrees with EPA Tier I modeling carried
out on cyhalofop-butyl. Therefore, drinking water will not be a
significant route of exposure. Dietary exposure is very low as
previously mentioned. In addition, a rotational crop study showed no
carryover of cyhalofop-butyl related residues in any representative
test crop. There are no residential uses for this compound. As a
result, the only potential for exposure is dietary, which is
acceptable. Therefore, aggregation of exposures is not necessary.
D. Cumulative Effects
The potential for cumulative effects of cyhalofop-butyl, cyhalofop-
acid and
[[Page 20811]]
other substances that have a common mechanism of toxicity is also
considered. There is no reliable information to indicate that toxic
effects produced by cyhalofop-butyl, cyhalofop-acid and cyhalofop-
diacid would be cumulative with those of any other pesticide chemical.
Thus, it is appropriate to consider only the potential risks of
cyhalofop-butyl and cyhalofop-acid in an aggregate exposure assessment.
E. Safety Determination
1. U.S. population. Using the conservative exposure assumptions
described above, and based on the completeness and reliability of the
toxicity data, aggregate exposure to cyhalofop-butyl, as determined
under the guidance of the FQPA, will utilize no more than 1.3% of the
reference dose (RfD) from the dietary exposure for all subgroups of the
U.S. population. Generally, and under the FQPA, EPA has no concern for
exposures below 100% of the RfD because the RfD represents the level at
or below which daily aggregate dietary exposure over a lifetime will
not pose appreciable risks to human health. Therefore, there is a
reasonable certainty that no harm will result from exposure to
cyhalofop-butyl residues.
2. Infants and children. Data from developmental toxicity studies
in rats and rabbits and a multigeneration reproduction study in the rat
are considered in assessing the potential for additional sensitivity of
infants and children to residues of cyhalofop-butyl. The developmental
toxicity studies are designed to evaluate adverse effects on the
developing organism resulting from pesticide exposure during prenatal
development. Reproduction studies provide information relating to
effects from exposure of both parents to the pesticide on the
reproductive capability and potential systemic toxicity of mating
animals and on various parameters associated with the well-being of
offspring. FFDCA section 408 provides that EPA may apply an additional
safety factor for infants and children in the case of threshold effects
to account for prenatal and postnatal toxicity and the completeness of
the data base. Based on the current toxicological data requirements,
the data base for cyhalofop-butyl relative to prenatal and postnatal
effects for children is complete. Overall, cyhalofop-butyl had no
effect on reproduction or embryo-fetal development at any dosage
tested. Further, for cyhalofop-butyl, the no observed adverse effect
level (NOAEL) in the chronic mouse study (0.3 mg/kg/day), which was
used to calculate the RfD (0.003 mg/kg/day), is already lower than the
NOAELs from the developmental studies in rats and rabbits. Therefore,
an additional FQPA uncertainty factor is not needed and the RfD at
0.003 mg/kg/day is appropriate for assessing risk to infants and
children. Using the conservative exposure assumptions previously
described, the percent RfD utilized by the potential aggregate exposure
to residues of cyhalofop-butyl on rice is about 1.3% for non-nursing
infants, the most sensitive population subgroup. Therefore, based on
the completeness and reliability of the toxicity data and the
conservative exposure assessment, Dow AgroSciences LLC concludes that
there is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to cyhalofop-butyl on rice.
F. International Tolerances
There is no Codex maximum residue level established for residues of
cyhalofop-butyl, cyhalofop-acid and cyhalofop-diacid on any food or
feed crop.
[FR Doc. 01-10122 Filed 4-24-01; 8:45 am]
BILLING CODE 6560-50-S
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Last Updated: Apr 25 15:59:12 2001
URL: http://www.epa.gov/fedrgstr/EPA-PEST/2001/April/Day-25/p10122.htm