[Federal Register Volume 66, Number 80 (Wednesday, April 25, 2001)]
[Notices]
[Pages 20808-20811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10122]


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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: 
[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'' 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: [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-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 g/g and 0.01-0.02 g/
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