FILE NAME: Fenarimol Filbert NOF. wpt ( 6/ 20/ 05)

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[ PP# 5E4573]

Summary of Petition EPA has received a pesticide petition ( PP 5E4573) from Interregional Research Project Number 4 ( IR 4), 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 fenarimol [ alpha( 2 chlorophenyl) alpha( 4 chlorophenyl) 5 pyrimidinemethanol] in or on the raw agricultural commodity filbert at 0.02 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 nature of the residue in fenarimol treated filbert has not been directly determined. Radioactive metabolism studies with apples and cherries indicate that fenarimol is the only significant component of the residue in apples and cherries. The residue of concern in filbert is fenarimol. 2 2. Analytical methodAnalytical methodology used for filbert is a slight modification of the basic PAM II method for fenarimol ( Method R039). Residues are extracted with methanol. Aqueous sodium chloride ( 5%) is added and the extract is partitioned with dichloromethane. Residues are cleaned up on a Florisil column and detected by GC/ ECD. Recoveries ranged from 84% to 97% in samples fortified with fenarimol at 0.02 ppm to 0.2 ppm. The limit of detection via this method is < 0.02 ppm. 3. Magnitude of residues. IR 4 data from 4 residue trials show residues of fenarimol were < 0.02 ppm in composite samples of filbert treated at 0.09 pound of active ingredient per acre ( lb ai/ A) and composite samples treated at 0.18 lb ai/ A or two times the proposed maximum application rate. These data indicate that fenarimol residues would not be expected to accumulate to significant levels in filbert. Based on these results and for purposes of this petition, it is appropriate to base the magnitude of total terminal residues and proposed tolerance only on residues of the parent compound, fenarimol. B. Toxicological Profile 1. Acute toxicity. The acute oral lethal dose ( LD 50 ) in the rat is 2,500 milligrams per kilogram ( mg/ kg) and the acute dermal LD 50 in the rabbit is > 2,000 mg/ kg. The inhalation lethal concentration ( LC 50 ) in the rat is > 2.04 mg/ liter of air, which is the highest obtainable respirable aerosol concentration. Fenarimol produced no indications of dermal irritation in rabbits or sensitization in the guinea pig. End use formulations of fenarimol have similar low acute toxicity profiles. 2. GenotoxictyFenarimol tested negative in several assay systems for gene mutation, structural chromosome aberration and other genotoxic effects. In a micronucleus test in the mouse, fenarimol did produce a significant increase in the percent of polychromatic erythrocytes with micronucleus at 24 hours but not at 48 or 72 hours. Moreover, a second test run at a higher dosage, which produced significant toxicity including death, was unequivocally negative.

3. Reproductive and developmental toxicityA developmental toxicity study in rabbits was negative for teratogenic effects at all doses tested ( 0, 5, 10, and 35 mg/ kg). A developmental toxicity study in rats demonstrated hydronephrosis at 35 mg/ kg ( doses tested were 0,5, 10, and 35 mg/ kg). A second developmental toxicity study in rats, with a postpartum evaluation, again demonstrated hydronephrosis at 35 mg/ kg. Maternal toxicity ( decreased body weight) was also observed at the 35 mg/ kg/ day dose level. The no observed effect level ( NOEL) for hydronephrosis and maternal toxicity is 13 mg/ kg.

4. Subchronic toxicity.

NA  Delete 5. Chronic toxicity. A 2 year chronic toxicity and carcinogenicity study in rats fed diets containing 0, 50, 130, or 350 ppm ( equivalent to 2.5, 6.5, or 17.5 mg/ kg/ day) resulted in a systemic NOEL of 130 ppm, equivalent to 6.5 mg/ kg/ day. An increase in fatty liver changes was observed in rats fed diets containing 350 ppm. There were no carcinogenic effects observed under the conditions 3 of the study. A second 2 year carcinogenicity study was conducted in rats fed diets containing 0, 12.5, 25, or 50 ppm, equivalent to 0, 0.63, 1.25, or 2.5 mg/ kg/ day. There was no apparent effect on survival, which was reduced in all treatment groups due to chronic respiratory disease. An increased incidence of fatty changes in the liver was observed at the top dose level of 50 ppm, and the NOEL was established as 25 ppm ( 1.2 mg/ kg/ day) in this study. A third 2 year carcinogenicity study was conducted at the same dose levels as above. The incidence of liver lesions was similar in the treated and control groups; thus the NOEL for liver effects in this study was greater than 50 ppm ( 2.5 mg/ kg/ day). A 2 year feeding study was conducted in mice fed diets containing concentrations of 0, 50, 170, or 600 ppm, equivalent to 0, 7, 24.3, or 85.7 mg/ kg/ day. The 600 ppm dose level was shown to increase liver weight. There was no increase in cancer, and no toxicologically significant treatment related effects were observed at any dose level. The NOEL was determined to be 600 ppm ( 85.7 mg/ kg/ day). In a 1 year chronic toxicity study, dogs were fed diets containing 0, 1.25, 12.5, or 125 mg/ kg/ day. The NOEL was 12.5 mg/ kg/ day based upon an increase in serum alkaline phosphatase, increased liver weights, an increase in p nitroanisole o demethylase activity, and mild hepatic bile stasis at the high dose level ( 125 mg/ kg/ day). Based on the chronic toxicity data, the chronic Reference Dose ( RfD) for fenarimol is established at 0.0006 mg/ kg/ day. The RfD for fenarimol is based on a 2 year chronic feeding study in rats with a NOEL of 6.5 mg/ kg/ day and an uncertainty factor of 1000. For short term (< 35 day) risk assessments to females 13  50 years old, the Agency selected a LOAEL of 35 mg/ kg/ day based upon decreased fertility and dystocia in rats and an uncertainty factor of 3000.

6. Animal metabolism. Metabolism studies conducted in rats show fenarimol is rapidly metabolized and excreted. Major metabolic pathways were oxidation of the carbinol carbon atom, the phenyl rings and the pyrimidine ring.

7. Metabolite toxicology. [ NA Remove]

8. Endocrine disruption. In a 3 generation reproduction study with rats and in subsequent special studies, fenarimol was determined to be a weak inhibitor of aromatase. Rats dosed at 0, 12.5, 25 or 50 ppm ( equivalent to 0, 0.625, 1.25 or 2.5 mg/ kg/ day) demonstrated decreased fertility in males at 25 ppm and delayed parturition and dystocia in females at 25 and 50 ppm. The NOEL for reproductive effects was 12.5 ppm ( 0.625 mg/ kg/ day). The infertility effect in males is considered to be a species specific effect mediated by the inhibition of aromatase, an enzyme which catalyzes the conversion of testosterone to estradiol. Estradiol plays an essential role in the developmental and maintenance of sexual behavior in rats. Multigeneration reproduction studies in guinea pigs and mice were negative for reproductive effects at the highest dose levels tested, 35 mg/ kg/ day and 20 mg/ kg/ day, respectively. A NOEL of 35 mg/ kg/ day for reproductive effects relevant to humans was established based on the NOEL from the 4 multigeneration reproduction study in guinea pigs. C. Aggregate Exposure 1. Dietary exposure i. Food For the purposes of assessing the potential dietary exposure from use on filbert, an estimate of aggregate exposure is determined by basing the TMRC from previously established tolerances and the proposed tolerance on filbert for fenarimol at 0.02 parts per million ( ppm) and assuming the 100% of the filbert crop has a residue of fenarimol at the tolerance level. Exposure of humans to residues could also result if such residues are transferred to meat, milk, poultry or eggs. Since there is no livestock feed commodity associated with filbert, there is no reasonable expectation that measurable secondary residues of fenarimol will occur in meat, milk, poultry or eggs under the terms of the proposed use. Other established tolerances for fenarimol on food or feed crops in the United States are established under 40 CFR part 180.421. The use of a tolerance level and 100% of crop treated clearly results in an overestimate of human exposure and a safety determination for use on filbert that is based on conservative exposure assessment. ii. Drinking water. Based upon the available environmental studies conducted with fenarimol wherein its properties show little potential for mobility in soil and extremely rapid photolysis in water, there is no anticipated exposure to residues of fenarimol in drinking water. 2. Non dietary exposure. The proposed use on filbert involves application of fenarimol to a crop grown in an agricultural environment. Thus, the potential for non occupational, non dietary exposure to the general population is not expected to be significant. There are no residential uses of fenarimol.

D. Cumulative Effects There is no evidence that there is a common mechanism of toxicity with any other chemical compound or that potential toxic effects of fenarimol would be cumulative with those of any other pesticide chemical. Thus it is believed that it is appropriate to consider only the potential risks of fenarimol in its exposure assessment. E. Safety Determination 1. U. S. population. It is concluded that aggregate exposure to fenarimol will utilize less than 2% of the chronic RfD for the U. S. general population and less than 14% of the acute RfD for females 13  50 at the 99.9 percentile level. EPA generally 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. It is concluded that there is a reasonable certainty that no harm will result from aggregate exposure to fenarimol residues in or on filbert. 2. Infants and children. In assessing the potential for additional sensitivity of infants and children to residues of fenarimol, data from developmental toxicity studies in rats and rabbits and a multigeneration reproduction study in the rat are considered. The developmental toxicity studies are 5 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 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 pre and post natal toxicity and the completeness of the data base. Based on the current toxicological data requirements, the data base for fenarimol relative to pre and post natal effects for children is complete. Further, for fenarimol, the NOEL in the chronic feeding study which was used to calculate the RID ( 6.5 mg/ kg/ day used by EPA or 1.2 mg/ kg/ day used by The World Health Organization) is already lower than the NOELs from the developmental studies in rats and rabbits. Concerning the multi generation reproduction study, the effects on reproduction are considered to be specific effect caused by aromatase inhibition. The aromatase enzyme promotes normal sexual behavior in rats and mice, but not in guinea pigs or primates, including humans. A NOEL of 35 mg/ kg/ day for reproductive effects relevant to humans was established based on the NOEL from the multigeneration reproduction study in guinea pigs. In addition, a NOEL of 13 mg/ kg/ day for developmental effects was established based upon the NOEL from the teratology study in rats. Therefore, it is concluded that an additional uncertainty factor is not needed and that the RfD at 0.065 mg/ kg/ day is appropriate for assessing risk to infants and children. F. International Tolerances There is no Codex or national maximum residue level established for fenarimol on filbert.


[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Notices]
[Page 11592]
[FR Doc No: 2017-03679]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4301-DR; Docket ID FEMA-2017-0001]

California; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of California (FEMA-4301-DR), dated February 14,
2017, and related determinations.

EFFECTIVE DATE:  February 14, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated February 14, 2017, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of California resulting from severe winter storms, flooding, and
mudslides during the period of January 3-12, 2017, is of sufficient
severity and magnitude to warrant a major disaster declaration under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121 et seq. (the ``Stafford Act''). Therefore, I declare
that such a major disaster exists in the State of California.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Timothy J. Scranton, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of California have been designated
as adversely affected by this major disaster:

    Alameda, Amador, Butte, Calaveras, Contra Costa, El Dorado,
Humboldt, Inyo, Lake, Lassen, Marin, Mendocino, Merced, Mono,
Monterey, Napa, Nevada, Placer, Plumas, Sacramento, San Benito, San
Luis Obispo, Santa Clara, Santa Cruz, Shasta, Sierra, Siskiyou,
Solano, Sonoma, Sutter, Trinity, Tuolumne, Yolo, and Yuba Counties
for Public Assistance.
    All areas within the State of California are eligible for
assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Robert J. Fenton,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-03679 Filed 2-23-17; 8:45 am]
 BILLING CODE 9111-23-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON D.C., 20460

	OFFICE  OF

	PREVENTION, PESTICIDES AND

	TOXIC SUBSTANCES

MEMORANDUM	PC Code No. 129106

	DP Barcode: D331978

									Date:   September 21, 2006

Subject: IR-4 Tolerance Petition for Cymoxanil (Tanos®) Use on
Caneberries: DW Assessment

To: 	Shaja Brothers, Risk Manager Reviewer

	Daniel Rosenblat, Risk Manager

	Registration Division (7505P)

From:	Dirk Young, Ph.D., Environmental Engineer

	Thomas Steeger, Ph.D., Senior Scientist

	Environmental Fate and Effects Division (7507P)

Thru:  Elizabeth Behl, Chief

	Environmental Risk Branch IV/EFED (7507

The Environmental Fate and Effects Division (EFED) has reviewed the
Inter-Region 4 (IR-4)  tolerance petition (DP Barcode D331978) for use
of cymoxanil (Tanos®) on caneberries to control Spur blight (Dydimella
appinata), anthracnose (Elsinoe veneta), Botrytis cane blight and fruit
rot (Botrytis cinerea) and Cladosporium fruit rot. Tanos® is a
formulated endproduct containing 25% famoxadone (PC Code 113202) and 25%
cymoxanil.  Only cymoxanil is considered in this assessment.  Based on
cymoxanil alone, the maximum proposed application rate for caneberries
is 0.19 lbs a.i./acre with a maximum of 6 applications.   The
reapplication interval is 7 days.  The maximum annual rate of cymoxanil
alone is 1.1 lbs a.i./acre.

	The newly proposed application rate is less than the rates evaluated in
the previous new use of cymoxanil grapes and hops (DP D323681).
Therefore no new drinking water concentrations are needed for the
proposed use.  Tier 1 drinking water concentrations based on the
previously assessed use on grapes appear in Table 1.  Environmental fate
data used for model input has been taken from the cymoxanil Section 3
assessment (DP Barcode D233366) for potatoes.

Table   SEQ Table \* ARABIC  1 .  Estimated drinking water
concentrations for Cymoxanil11

	Acute  (µg/L)	Chronic  (µg/L)

Groundwater1	0.003	0.003

Surface Water2	19	0.10

1. Concentrations determined from the grape application (0.25 lbs per
acre, 10 times), which was the highest application rate reported for the
new proposed uses.

Environmental Fate Summary.

Cymoxanil hydrolyzes rapidly under both alkaline and neutral media (34
hours at pH 7, 31 minutes at pH 9) but degrades slowly under acidic
conditions (148 days at pH 5).  Cymoxanil photodegrades quickly (1.8
days) in near-surface aqueous media, and dissipates readily in aerobic
and anaerobic soils with half lives on the order of hours to days.
Major degradates formed from these processes generally degraded quickly
with half-lives on the order of days.  Field dissipation studies of
cymoxanil showed dissipation half lives of from 1 day (in Maryland) to
8.7 days in California) and also showed no detections of cymoxanil 15 cm
for the duration of the test.   Cymoxanil is moderately mobile with a
mean Koc of about 120 ml/g.

Drinking Water Assessment

A Tier 1 drinking water assessment was performed using FIRST (version
1.0) for surface water and SciGRow (version 2.3) for groundwater. Input
parameters were chosen per current EFED guidance and appear in Tables 2
and 3.  Output for the two models appears in Table 1.

Table   SEQ Table \* ARABIC  2 . FIRST (ver 1.0) model inputs for
cymoxanil drinking water estimate

Input Name	Value	Reference

Application	0.25 lb/acre, 10 times, 7 days apart	Label for grapes

PCA	0.87	Default  (EFED Input Parameter Guidance 2000)

Kd	0.29	Lowest non-sand value, (EFED Input Parameter Guidance 2000

Aerobic soil metabolism half life	3.6 days	Calculated from the single
available value for US soil by multiplying by 3.  See section 3.

Application Method	aerial	Label

Wetted in?	no	Label

Water solubility	78	See section 3.

Hydrolysis (pH =7)	1.4 days	MRID 44180738

Aerobic aquatic metabolism half life	7.2 days	In the absence of data,
the aerobic soil metabolism input was multiplied by 2  (EFED Input
Parameter Guidance 2000

Aqueous photolysis

half life	1.8 days	MRID 44180739, 44180740

Table 3. SCIGROW (ver 2.3) model inputs for cymoxanil groundwater
concentration estimate

Input Name	Value	Reference

Application	2.5 lb total	Label for grapes

Koc	39 ml/g	Lowest Koc 1

Aerobic soil metabolism

Half-life	1.2 days	Single measured value reported in 7/11/02 review
(D275802) of MRID 44180743.

1. Koc values of 39, 110, 240, 106 derived from Freundlich coefficients
of 0.29, 2.86, 1.38, 1 and 0.70 and organic matter contents of 1.3, 4.5,
1, and 1.3 percent, respectively.

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