UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES March 30, 2005 MEMORANDUM Subject: Petition Number: 4E6859 Dietary Exposure and Risk Analysis for the Proposed Interregional Research Project No. 4 ( IR 4) Use of Fenhexamid on Ginseng PC Code: 090209 DP Barcode: D312267 Decision Number: 351273 From: Breann Hanson, Biologist John Redden, Senior Scientist ARIA Team Registration Division ( 7505C)

Through: W. Cutchin, Chemist Technical Review Branch Registration Division ( 7505C)

To: Sidney Jackson, RM 05 MUIER Branch Registration Division ( 7505C)

ACTION REQUESTED The purpose of this memorandum is to provide a Tier 1 chronic dietary exposure analysis for the proposed IR 4 use of fenhexamid on commercially grown ginseng. The proposed tolerance level of 0.3 ppm was recommended by TRB ( Cutchin, D312266, Decision Number: 351273, 03/ 07/ 2005). In this analysis, the chronic dietary exposures and risk estimates resulting from food intake were determined for the general U. S. population and various population subgroups.

EXECUTIVE SUMMARY A chronic Tier 1 dietary exposure to fenhexamid analysis ( assuming tolerance level residues, default processing factors, and 100 percent crop treated (% CT) information) was conducted for fenhexamid. Based on the toxicological data, an acute dietary analysis for fenhexamid is not required. This analysis incorporates all current, pending, and proposed tolerances for fenhexamid as of February 17, 2005. The chronic dietary risk assessment indicates that for all registered and proposed commodities, the chronic dietary risk estimates are below HED's level of concern (< 100% chronic population adjusted dose ( cPAD)) for the general U. S. population ( 10% of the cPAD) and all population subgroups. The chronic dietary exposure estimate for the highest exposed population subgroup ( children 1 2 years old) is 68% of the cPAD.

The toxicology and residue chemistry databases are adequate to support the following tolerance for the combined residues of the fungicide fenhexamid and registration for the use of fenhexamid on Ginseng Group 1AB in terms of human health risk:

Ginseng Group 1AB  0.3 ppm Refinement using anticipated residues ( ARs), processing factors, and percent crop treated (% CT) data would result in even lower chronic exposure estimates.

Fenhexamid has been classified as a " not likely" human carcinogen according to the EPA Proposed Guidelines for Carcinogen Risk Assessment ( April 10, 1996). This classification is based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice and on the lack of genotoxicity in an acceptable battery of mutagenicity studies.

I. Introduction Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose. This is the population adjusted dose ( PAD), which HED has concluded will result in no unreasonable adverse health effects. The PAD is the Reference Dose ( RfD) divided by the special FQPA Safety Factor. Dietary risk is expressed as a percentage of the PAD. For acute and noncancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. HED is generally concerned when estimated cancer risk exceeds one in one million ( i. e., the risk exceeds 1 x 10 6). References which discuss the acute and chronic risk assessments in more detail are available on the EPA/ pesticides web site: " Available Information on Assessing Exposure from Pesticides, A User's Guide", 6/ 21/ 2000, web link: http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf ; or see SOP 99.6 ( 8/ 20/ 99).

The most recent dietary risk assessment for fenhexamid was conducted by Eugenia McAndrew; DP Barcode: D305979; August 4, 2004.

II. Residue Information ACTIVE INGREDIENT: Fenhexamid RESIDUE OF CONCERN: On 3/ 2/ 99 the HED Metabolism Assessment Review Committee concluded that the tolerance expression for fungicide fenhexamid [ N( 2,3 dichlor 4 hydroxyphenyl) 1 methyl cyclohexanecarboxamide] need only consider the parent compound ( Herndon; D253792; 3/ 2/ 99). Tolerances for residues of fenhexamid, ranging from 0.02 to 6.0 ppm, have been established ( 40 CFR 180.553) for a number of agricultural commodities. For this chronic dietary exposure analysis, tolerance level residues were used for all commodities with registered or proposed uses ( Attachment 1). Default processing factors in the DEEM   software were used for all commodities except processed tomato commodities. This application is for Ginseng Group 1AB.

The following conservative assumptions were made for the chronic dietary analysis: HEDrecommended tolerance level residues ( associated with the current petition and previously registered uses), default processing factors for all RACs, and all RACs were 100% treated with fenhexamid. Additional refinement using ARs, processing factors, and % CT data would result in even lower chronic exposure estimates.

III. DEEM FCID   Program and Consumption Information The Fenhexamid chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEM FCID   , Version 1.3), which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII), 1994 1996 and 1998. The 1994 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non consecutive survey days. Foods " as consumed" ( e. g., apple pie) are linked to EPA defined food commodities ( e. g. apples, peeled fruit  cooked; fresh or N/ S; baked; or wheat flour  cooked; fresh or N/ S, baked) using publicly available recipe translation files developed jointly by USDA/ ARS and EPA. Consumption data are averaged for the entire U. S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment.

For chronic exposure and risk assessment, an estimate of the residue level in each food or foodform ( e. g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/ kg body weight/ day and as a percent of the cPAD. This procedure is performed for each population subgroup.

IV. Toxicological Information On March 26, 2003 the Health Effects Division ( HED) Hazard Identification Assessment Review Committee ( HIARC) reassessed FQPA requirements in response to questions posed by the Natural Resources Defense Council ( NRDC). No new data have been reviewed and no changes were made to the toxicology endpoints previously selected for Fenhexamid ( with the exception of the FQPA safety factor applied). This document revises the previous HIARC report dated March 4, 1999 ( HED DOC. NO. 013258).

The HIARC concluded that there is low concern for pre and/ or postnatal toxicity resulting from exposure to Fenhexamid. The HIARC determined that no special FQPA safety factor is needed ( i. e. 1X) since there are no residual uncertainties for pre and/ or post natal toxicity. In addition the HIARC concluded that there is not a concern for developmental neurotoxicity resulting from exposure to Fenhexamid. The HIARC classified Fenhexamid as a " not likely" human carcinogen according to the EPA Proposed Guidelines for Carcinogen Risk Assessment ( April 10, 1996). This classification is based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice and on the lack of genotoxicity in an acceptable battery of mutagenicity studies.

Table 1. Summary of Toxicological Dose and Endpoints Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( General Population including infants and children) None UF = NA Acute RfD = None FQPA SF = 1X aPAD = acute RfD FQPA SF = None Not selected. No appropriate toxicological endpoint attributable to a single exposure was identified in the available toxicology studies.

Chronic Dietary ( All populations) NOAEL = 17 mg ai/ kg/ day UF = 100 Chronic RfD = 0.17 mg/ kg/ day 1X cPAD = chronic RfD FQPA SF = 0.17 mg/ kg/ day 1 Year Feeding Dog. Decreased RBC count, hemoglobin and hematocrit and increased Heinz bodies in males and females; increased adrenal weights and intracytoplasmic vacuoles in adrenal cortex in females at the LOAEL of 124 mg/ kg/ day.

* NOTE: The Special FQPA Safety Factor recommended by the HIARC assumes that the exposure databases ( dietary food, drinking water, and residential) are complete and that the risk assessment for each potential exposure scenario includes all metabolites and/ or degradates of concern and does not underestimate the potential risk for infants and children.

V. Results/ Discussion As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the cPAD. The DEEM FCID   analyses estimate the dietary exposure of the U. S. population and 26 population subgroups. The results reported in Table 2 are for the general U. S. Population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, females 13 49, adults 20 49 and adults 50+ years. The results for the other population subgroups are included in Attachment 2.

Table 2. Summary of Tier 1 Estimates of Exposure and Risk from Chronic Dietary Exposure to Fenhexamid Population Subgroup Exposure, mg/ kg bwt/ day % cPAD U. S. Pop  48 states  all seasons 0.017489 10 All infants (< 1 year) 0.086111 51 Children ( 1 2 years) 0.115348 68 Children ( 3 5 years) 0.070176 41 Females ( 13 49 years) 0.008387 5 Youths ( 13 19 years) 0.009446 6 Adults ( 20 49 years) 0.007415 4 Seniors ( 50+ years) 0.009274 6 VI. Conclusions The chronic dietary exposure and risk assessment indicates that for all registered uses and including the proposed section 3 uses of fenhexamid on Ginseng Group 1AB, the chronic dietary risk estimates are below HED's level of concern (< 100% cPAD) for the general U. S. population ( 10% of the cPAD) and all population subgroups. The chronic dietary exposure estimate for the highest exposed population subgroup ( children 1 2 years old) is 68% of the cPAD. Refinement using ARs, processing factors, and % CT data would result in even lower chronic exposure estimates.

Table 3. Summary of Dietary Exposure and Risk for Fenhexamid Population Subgroup** Chronic Dietary Cancer Dietary Exposure ( mg/ kg/ day) % cPAD Risk General U. S. Population 0.017489 10 N/ A All Infants (< 1 year old) 0.086111 51 N/ A Children 1 2 years old 0.115348 68 Table 3. Summary of Dietary Exposure and Risk for Fenhexamid Population Subgroup** Chronic Dietary Cancer Dietary Exposure ( mg/ kg/ day) % cPAD Risk Children 3 5 years old 0.070176 41 Children 6 12 years old 0.025800 15 Youth 13 19 years old 0.009446 6 Adults 20 49 years old 0.007415 4 Females 13 49 years old 0.008387 5 Adults 50+ years old 0.009274 6 Attachment 1  Residue Inputs for Tier 1 Dietary Assessment of Fenhexamid U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for FENHEXAMID 1994 98 data Residue file: C:\ My Documents\ Breann's Work\ ARIA\ Fenhexamid\ Fenhexamid R98. R98 Adjust. # 2 NOT used Analysis Date 02 16 2005 Residue file dated: 02 16 2005/ 09: 17: 42/ 8 Reference dose ( RfD) = 0.17 mg/ kg bw/ day  Food Crop Residue Adj. Factors Comment EPA Code Grp Food Name ( ppm) # 1 # 2        14000030 14 Almond 0.020000 1.000 1.000 14000031 14 Almond babyfood 0.020000 1.000 1.000 11000070 11 Apple, fruit with peel 10.000000 1.000 1.000 11000080 11 Apple, peeled fruit 10.000000 1.000 1.000 11000081 11 Apple, peeled fruit babyfood 10.000000 1.000 1.000 11000090 11 Apple, dried 10.000000 1.000 1.000 11000091 11 Apple, dried babyfood 10.000000 1.000 1.000 11000100 11 Apple, juice 10.000000 1.000 1.000 11000101 11 Apple, juice babyfood 10.000000 1.000 1.000 11000110 11 Apple, sauce 10.000000 1.000 1.000 11000111 11 Apple, sauce babyfood 10.000000 1.000 1.000 12000120 12 Apricot 6.000000 1.000 1.000 12000121 12 Apricot babyfood 6.000000 1.000 1.000 12000130 12 Apricot, dried 6.000000 6.000 1.000 12000140 12 Apricot, juice 6.000000 1.000 1.000 12000141 12 Apricot, juice babyfood 6.000000 1.000 1.000 13010550 13A Blackberry 20.000000 1.000 1.000 13010560 13A Blackberry, juice 20.000000 1.000 1.000 13010561 13A Blackberry, juice babyfood 20.000000 1.000 1.000 13020570 13B Blueberry 5.000000 1.000 1.000 13020571 13B Blueberry babyfood 5.000000 1.000 1.000 13010580 13A Boysenberry 20.000000 1.000 1.000 12000900 12 Cherry 6.000000 1.000 1.000 12000901 12 Cherry babyfood 6.000000 1.000 1.000 12000910 12 Cherry, juice 6.000000 1.500 1.000 12000911 12 Cherry, juice babyfood 6.000000 1.500 1.000 11001290 11 Crabapple 10.000000 1.000 1.000 13021360 13B Currant 5.000000 1.000 1.000 13011420 13A Dewberry 20.000000 1.000 1.000 13021490 13B Elderberry 5.000000 1.000 1.000 01011680 1AB Ginseng, dried 0.300000 1.000 1.000 13021740 13B Gooseberry 5.000000 1.000 1.000 95001750 O Grape 4.000000 1.000 1.000 95001760 O Grape, juice 4.000000 1.200 1.000 95001761 O Grape, juice babyfood 4.000000 1.200 1.000 95001770 O Grape, leaves 4.000000 1.000 1.000 95001780 O Grape, raisin 6.000000 4.500 1.000 95001790 O Grape, wine and sherry 4.000000 0.500 1.000 13021910 13B Huckleberry 5.000000 1.000 1.000 13012080 13A Loganberry 20.000000 1.000 1.000 11002100 11 Loquat 10.000000 1.000 1.000 12002300 12 Nectarine 6.000000 1.000 1.000 12002600 12 Peach 6.000000 1.000 1.000 12002601 12 Peach babyfood 6.000000 1.000 1.000 12002610 12 Peach, dried 6.000000 7.000 1.000 12002611 12 Peach, dried babyfood 6.000000 7.000 1.000 12002620 12 Peach, juice 6.000000 1.000 1.000 12002621 12 Peach, juice babyfood 6.000000 1.000 1.000 11002660 11 Pear 10.000000 1.000 1.000 11002661 11 Pear babyfood 10.000000 1.000 1.000 11002670 11 Pear, dried 10.000000 6.250 1.000 11002680 11 Pear, juice 10.000000 1.000 1.000 11002681 11 Pear, juice babyfood 10.000000 1.000 1.000 14002820 14 Pistachio 0.020000 1.000 1.000 12002850 12 Plum 0.500000 1.000 1.000 12002851 12 Plum babyfood 0.500000 1.000 1.000 12002870 12 Plum, prune, dried 1.000000 5.000 1.000 12002871 12 Plum, prune, dried babyfood 1.000000 5.000 1.000 12002880 12 Plum, prune, juice 0.500000 1.400 1.000 12002881 12 Plum, prune, juice babyfood 0.500000 1.400 1.000 11003100 11 Quince 10.000000 1.000 1.000 13013200 13A Raspberry 20.000000 1.000 1.000 13013201 13A Raspberry babyfood 20.000000 1.000 1.000 95003590 O Strawberry 3.000000 1.000 1.000 95003591 O Strawberry babyfood 3.000000 1.000 1.000 95003600 O Strawberry, juice 3.000000 1.000 1.000 95003601 O Strawberry, juice babyfood 3.000000 1.000 1.000 08003750 8 Tomato 2.000000 1.000 1.000 08003751 8 Tomato babyfood 2.000000 1.000 1.000 Attachment 2  Results of Tier 1 Chronic Dietary Analysis for Fenhexamid U. S. Environmental Protection Agency Ver. 2.00 DEEM FCID Chronic analysis for FENHEXAMID ( 1994 98 data) Residue file name: C:\ My Documents\ Breann's Work\ ARIA\ Fenhexamid\ Fenhexamid R98. R98 Adjustment factor # 2 NOT used. Analysis Date 02 16 2005/ 09: 19: 05 Residue file dated: 02 16 2005/ 09: 17: 42/ 8 Reference dose ( RfD, Chronic) = .17 mg/ kg bw/ day =============================================================================== Total exposure by population subgroup  Total Exposure  Population mg/ kg Percent of Subgroup body wt/ day Rfd    U. S. Population ( total) 0.017489 10.3%

U. S. Population ( spring season) 0.017162 10.1% U. S. Population ( summer season) 0.016851 9.9% U. S. Population ( autumn season) 0.018252 10.7% U. S. Population ( winter season) 0.017658 10.4%

Northeast region 0.019929 11.7% Midwest region 0.017521 10.3% Southern region 0.014953 8.8% Western region 0.019293 11.3%

Hispanics 0.019275 11.3% Non hispanic whites 0.017276 10.2% Non hispanic blacks 0.016507 9.7% Non hisp/ non white/ non black 0.019482 11.5%

All infants (< 1 year) 0.086111 50.7% Nursing infants 0.048827 28.7% Non nursing infants 0.100265 59.0% Children 1 6 yrs 0.080530 47.4% Children 7 12 yrs 0.022879 13.5%

Females 13 19 ( not preg or nursing) 0.010451 6.1% Females 20+ ( not preg or nursing) 0.008358 4.9% Females 13 50 yrs 0.010106 5.9% Females 13+ ( preg/ not nursing) 0.015080 8.9% Females 13+ ( nursing) 0.013403 7.9%

Males 13 19 yrs 0.008439 5.0% Males 20+ yrs 0.007603 4.5% Seniors 55+ 0.009624 5.7%

Children 1 2 yrs 0.115348 67.9% Children 3 5 yrs 0.070176 41.3% Children 6 12 yrs 0.025800 15.2% Youth 13 19 yrs 0.009446 5.6% Adults 20 49 yrs 0.007415 4.4% Adults 50+ yrs 0.009274 5.5% Females 13 49 yrs 0.008387 4.9%


[Federal Register: August 2, 2006 (Volume 71, Number 148)]
[Notices]
[Page 43742-43744]
[DOCID:fr02au06-68]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0352; FRL-8080-8]

Sodium Cyanide; Tolerance Reassessment Decision for Low Risk
Pesticide; Notice of Availability

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  This notice announces the availability of EPA's Tolerance
Reassessment Decision (TRED) for the pesticide sodium cyanide, and
opens a public comment period on this document, related risk
assessments, and other support documents. EPA has reviewed this
pesticide sodium cyanide through a modified, streamlined version of the
public participation process that the Agency uses to involve the public
in developing pesticide tolerance reassessment and reregistration
decisions. Through the tolerance reassessment program, EPA is ensuring
that all pesticides meet current health and food safety standards.

DATES:  Comments must be received on or before October 2, 2006.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0352, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0352. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other

material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours
of operation of this Docket Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Wilhelmena Livingston, Special Review
and Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes 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 docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2.  Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
     iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
     viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

     EPA has reassessed the uses of sodium cyanide, reassessed the one
existing tolerance or legal residue limit established for residues of
the insecticide hydrogen cyanide as a result of application of sodium
cyanide, and on July 13, 2006, reached a tolerance reassessment
decision for this pesticide. Sodium cyanide is used as a predacide/
rodenticide and as an insecticide. As a predacide/rodenticide, it is
used as a single dose poison in the M-44 ejector device to control
animals that prey upon livestock and threatened or endangered species
or that are vectors of communicable disease. The eligibility of the
predacide/rodenticide use was determined in the September 1994
Reregistration Eligibility Decision document (RED) published in the
Federal Register on January 25, 1995 (60 FR 4910) (FRL-4391-9). As an
insecticide, sodium cyanide is used in California to control red scale
on fresh market citrus bound for Arizona. It is applied by professional
applicators as a post-harvest fumigant. Although a TRED typically does
not include an occupational assessment, the decision document addresses
potential occupational exposures that were not addressed in the 1994
RED.
    The Agency is now issuing for comment the resulting Report on Food
Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk
Management Decision for sodium cyanide, known as a TRED, as well as
related risk assessments and technical support documents.
    EPA developed the sodium cyanide TRED through a modified,
streamlined version of its public process for making tolerance
reassessment and reregistration eligibility decisions. Through these
programs, the Agency is ensuring that pesticides meet current standards
under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by
FQPA. EPA must review tolerances and tolerance exemptions that were in
effect when FQPA was enacted, to ensure that these existing pesticide
residue limits for food and feed commodities meet the safety standard
established by the new law. Tolerances are considered reassessed once
the safety finding has been made or a revocation occurs. EPA has
reviewed and made the requisite safety finding for the sodium cyanide
tolerances included in this notice.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register of May 14,
2004 (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, the Agency is tailoring its public participation process to
be commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
EPA can expeditiously reach decisions for pesticides like sodium
cyanide, which pose no risk concerns, and require no risk mitigation.
Once EPA assesses uses and risks for such low risk pesticides, the
Agency may go directly to a decision and prepare a document summarizing
its findings, such as the sodium cyanide TRED.
    The tolerance reassessment program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public in finding ways to
effectively mitigate pesticide risks. Sodium cyanide, however, poses no
risks that require mitigation. The Agency therefore is issuing the
sodium cyanide TRED, its risk assessments, and related support
documents simultaneously for public comment. The comment period is
intended to provide an opportunity for public input and a mechanism for

initiating any necessary amendments to the TRED. All comments should be
submitted using the methods in ADDRESSES, and must be received by EPA
on or before the closing date. These comments will become part of the
Agency Docket for sodium cyanide. Comments received after the close of
the comment period will be marked ``late.'' EPA is not required to
consider these late comments.
    EPA will carefully consider all comments received by the closing
date and will provide a Response to Comments Memorandum in the Docket
and regulations.gov. If any comment significantly affects the document,
EPA also will publish an amendment to the TRED in the Federal Register.
In the absence of substantive comments requiring changes, the decisions
reflected in the TRED will be implemented as presented.

B. What is the Agency's Authority for Taking this Action?

    Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
is to be completed by August 3, 2006.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 21, 2006.
 Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-12346 Filed 7-1-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: September 3, 2010 (Volume 75, Number 171)]
[Notices]
[Page 54215]
[DOCID:fr03se10-117]

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DEPARTMENT OF TRANSPORTATION

[Docket No. DOT-OST-2010-0212]

Agency Request for Approval of a Previously Approved Information
Collection(s): Uniform Administrative Requirements for Grants and
Cooperative Agreements to State and Local Governments and for Grants
and Cooperative Agreements With Institutions of Higher Education,
Hospitals, and Other Nonprofit Organizations

AGENCY: Office of the Secretary.

ACTION: Notice and request for comments.

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SUMMARY: The Department of Transportation (DOT) invites public comments
about our intention to request Office of Management and Budget (OMB)
approval to renew a previously approved information collection. This
information collection involves the use of various forms necessary
because of management and oversight responsibilities of the agency
imposed by OMB Circular 2 CFR 215 (A-110) (Uniform Administrative
Requirements for Grants and Agreements with Institutions of Higher
Education, Hospitals, and Other Non-Profit Organizations) and OMB
Circular A-102 (Uniform Administrative Requirements for Grants and
Cooperative Agreements to State and Local Governments). These forms
include Application for Federal Assistance (SF-424), Federal Financial
Report (SF-425), Request for Advance or Reimbursement (SF-270), and
Outlay Report and Request for Reimbursement for Construction Programs
(SF-271).
    The Department has terminated Financial Status Report (SF-269 and
SF-269A) and Federal Cash Transactions Report (SF-272 and SF-272A). The
information contained in these forms is now consolidated into SF-425,
which was approved by OMB for Federal-wide use on October 1, 2008 and
recently revised on June 28, 2010. We are required to publish this
notice in the Federal Register in accordance with the Paperwork
Reduction Act of 1995, Public Law 104-13.

DATES: Written comments must be submitted November 2, 2010.

ADDRESSES: You may submit comments identified by Docket No. DOT-OST-
2010-0212 through one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail or Hand Delivery: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue, SE., West
Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except on Federal holidays.

FOR FURTHER INFORMATION CONTACT: Ellen Shields, Associate Director of
the Financial Assistance Management Division, M-65, Office of the
Senior Procurement Executive, Office of the Secretary, U.S. Department
of Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590,
(202) 366-4268. Refer to OMB Control Number 2105-0520.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2105-0520.
    Title: Uniform Administrative Requirements For Grants and
Cooperative Agreements to State and Local Governments and For Grants
and Cooperative Agreements with Institutions of Higher Education,
Hospitals, and Other Nonprofit Organizations.
    Form Numbers: SF-424, SF-425, SF-270, and SF-271.
    Type of Request: Revision of a previously approved collection.
    Abstract: This request combines two previously approved Information
Collection Requests (ICR) (OMB Control numbers 2105-0531 and 2105-0520)
into OMB Control Number 2105-0520. The Department is also requesting
the renewal of information and collection requirements imposed by OMB
Circular A-110 (Uniform Administrative Requirements for Grants and
Agreements with Institutions of Higher Education, Hospitals, and Other
Non-Profit Organizations, which the Department of Transportation
codified at 49 CFR 18.40, 18.41 and 19), and OMB Circular 102 (Uniform
Administrative Requirements for Grants and Cooperative Agreements to
State and Local Governments). OMB provides management and oversight of
the circulars. OMB also provides for a standard figure of seventy
burden hours per grantee annually for completion of required forms.
This collection covers only those DOT programs that utilize the
standard OMB forms SF-424, SF-425, SF-270, and SF-271. The Department
requests the Discontinuance of SF-269, SF-269A, SF-272, and SF-272A as
well as OMB Control Number 2105-0531.
    The Department's request for approval of the Federal Financial
Report (FFR) (SF-425) is based on the Federal Register notice dated
August 13, 2008, which states ``As soon as possible after October 1,
2008, and no later than October 1, 2009, each agency must transition
from the SF-269, SF-269A, SF-272, and SF-272A to the SF-425, by
requiring recipients to use the FFR for all financial reports submitted
after the date it makes the transition. In making the transition, an
agency would incorporate the requirement to use the FFR into terms and
conditions of new and ongoing grant and cooperative agreement awards,
State plans, and/or program regulations that specify financial
reporting requirements.'' Comments on this notice were received and
addressed in a Federal Register notice dated August 13, 2008 (72 FR,
69236). These comments and responses can be found on the OMB Forms Web
site at http://www.whitehouse.gov/omb/grants/grants_standard_report_
forms.html.
    Respondents: Grantees.
    Estimated Number of Respondents: 3,329.
    Estimated Frequency: Quarterly.
    Estimated Number of Responses: 10,814.
    Estimated Total Annual Burden: 756,980 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (a) Whether the proposed
collection of information is necessary for the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department to enhance the quality, utility and clarity of the
information collection; and (d) ways that the burden could be minimized
without reducing the quality of the collected information. All
responses to this notice will be summarized and included in the request
for OMB approval. All comments will also become a matter of public
record.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1.48.

    Issued in Washington, DC, on August 30, 2010.
Patricia Lawton,
DOT Paperwork Reduction Act Clearance Officer, Office of the Chief
Information Officer.
[FR Doc. 2010-22048 Filed 9-2-10; 8:45 am]
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