MEMORANDUM 7/ 29/ 2001 SUBJECT: Residue Chemistry Chapter For The Diuron Reregistration Eligibility Decision ( RED) Document.

DP Barcode: D274492 Chemical No. 035505 Case No: 0046 FROM: John S. Punzi, Ph. D., Chemist ( Signed 8/ 7/ 2001) Reregistration Branch 2 Health Effects Division [ 7509C]

THRU: Alan Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division [ 7509C]

TO: Diana Locke, Ph. D., Risk Assessor Reregistration Branch 2 Health Effects Division [ 7509C]

Attached is the Residue Chemistry Chapter for the Diuron Reregistration Eligibility Decision ( RED) document. This chapter was completed by the Dynamac Corporation under supervision of HED and has undergone secondary review/ modification in Reregistration Branch 2 for consistency with current EPA policies. This document was reviewed by the ChemSac on 7/ 25/ 01 and recommendations have been incorporated.

The existing residue chemistry database is incomplete.

Label revisions are required for many crops in order to reflect the parameters of use patterns for which residue data are available. Many of the revisions concern retreatment intervals, Preharvest intervals ( PHI's) and rotational crop restrictions.

The qualitative nature of the residue of diuron in plants and animals has been adequately identified/ characterized. The Agency is recommending that the tolerance expression for diuron be revised to include metabolites hydrolyzable to 3,4 dichloroaniline.

Adequate analytical methods exist for data collection and tolerance enforcement in plants. Independent laboratory validation of the enforcement method is required for livestock methods prior to Agency validation. Multiresidue methods for diuron and metabolites of toxic concern are required for plants and livestock.

Adequate storage stability data are available for many supported crops.

Results from animal feeding studies suggest that tolerances are necessary for poultry or egg commodities and for meats and milk. Residue data are not available for several potential feed items. If the maximum dietary burden does not increase when recalculated from all potential feed items after acceptable field trial data are submitted then the established tolerances for residues in fat, meat, and meat byproducts of cattle, goats, hogs, horses, and sheep can be lowered.

Adequate residue data exist for some processed food/ feed commodities.

The reregistration requirements for magnitude of the residue in plants are not fulfilled for: alfalfa forage; globe artichoke; barley hay; cotton gin byproducts; field corn aspirated grain fractions; field corn forage and stover; filbert; grass forage, hay, seed screenings, and straw; lemon; pear; oat forage, hay; olive; field pea vines and hay; sorghum aspirated grain fractions, stover, and forage; wheat forage and hay. Additional crop field trial data are required for these commodities.

The reregistration requirements for magnitude of the residue in plants are fulfilled for: alfalfa hay; apple; asparagus; banana; barley grain, straw; blackberry; blueberry; clover forage and hay; field corn grain; popcorn grain and popcorn stover; cotton seed; gooseberry; grape; grapefruit; loganberry; macadamia nut; oat grain and straw; orange; papaya; field pea seed; peach; pecan; peppermint; pineapple; raspberry; sorghum grain; sugarcane; trefoil forage and hay; vetch forage and hay; walnut; and wheat grain, aspirated grain fractions, and straw. Adequate field trial data depicting diuron residues of concern following applications made according to the maximum registered use patterns have been submitted for these commodities or data have been translated from appropriate crops.

The registrants have indicated that a Section 3 tolerance for diuron in/ on catfish is desired. Since the metabolism committee is concerned with a monochloronated diuron metabolite identified in water, a metabolism study of diuron in fish is required. The registrants are directed to OPPTS 860.1400 for study guidelines and encouraged to submit a study protocol prior to initiating the study.

Field rotational crop trials have been conducted on representative crops at less that the maximum application rates with 1 year plant back intervals and some labels indicate a 2 year plant back interval. RRB2 recommends that the registrants provide additional data to support the higher application rate and believes that the 2 yr PBI is not practical. The registrants should remove the 2 yr PBI from the registered uses and provide data to support the 3.2 lb ai/ A application rate and 1 yr PBI. Until adequate data are supplied labels should be amended to restrict rotational crops to those crops which currently are registered as primary crops..

cc: JSPunzi ( RRB2), Diuron Reg. Std. File, Diuron SF, RF, LAN. 7509C: RRB2: John S. Punzi: CM2: Rm 712M: 703 305 7727: 07/ 29/ 2000.

Diuron PC Code 035505; Case 0046 DP Barcode D274492 Reregistration Eligibility Decision; Residue Chemistry Considerations May 29, 2001 Contract No. 68 W 99 053 Submitted to: U. S. Environmental Protection Agency Arlington, VA Submitted by: Dynamac Corporation The Dynamac Building 2275 Research Boulevard Rockville, MD 20850 3268 DIURON REREGISTRATION ELIGIBILITY DECISION RESIDUE CHEMISTRY CONSIDERATIONS PC Code 035505; Case 0046 ( DP Barcode D274492)

TABLE OF CONTENTS page INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 REGULATORY BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 SUMMARY OF SCIENCE FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 GLN 860.1200: Directions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 GLN 860.1300: Nature of the Residue  Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 GLN 860.1300: Nature of the Residue  Livestock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 GLN 860.1340: Residue Analytical Methods  Plants and Livestock . . . . . . . . . . . . . . . . . . 32 GLN 860.1360: Multiresidue Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 GLN 860.1380: Storage Stability Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Plant commodities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Livestock commodities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 GLN 860.1500: Crop Field Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Legume Vegetables Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Pea, field, seed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Foliage of Legume Vegetables Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Pea, field, vines and hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Citrus Fruit Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Grapefruit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Lemon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Orange . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Pome Fruit Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Apple . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Pear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Stone Fruit Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Peach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Berry Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Blackberry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Blueberry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Gooseberry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Loganberry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Table of Contents ( continued) page v Raspberry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Tree Nut Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Filbert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Macadamia nut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Pecan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Walnut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Cereal Grains Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Barley, grain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Corn, field, grain and aspirated grain fractions . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Corn, pop, grain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Corn, sweet, K+ CWHR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Oat, grain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Sorghum, grain and aspirated grain fractions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Wheat, grain and aspirated grain fractions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Forage, Fodder, and Straw of Cereal Grains Group . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Barley, hay and straw . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Corn, field, forage and stover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Corn, pop, stover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Corn, sweet, forage and stover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Oat, forage, hay, and straw . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Sorghum, forage and stover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Wheat, forage, hay, and straw . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Grass Forage, Fodder, and Hay Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Grass, forage, hay, seed screenings, and seed straw . . . . . . . . . . . . . . . . . . . . . . 41 Nongrass Livestock Feeds ( Forage, Fodder, Hay, and Straw) Group . . . . . . . . . . . . . 42 Alfalfa, forage and hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Clover, forage and hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Trefoil, forage and hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Vetch, forage and hay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Miscellaneous Commodities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Artichoke, globe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Asparagus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Banana . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Cotton, seed and gin byproducts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Grape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Olive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Papaya . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Peppermint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Pineapple . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Sugarcane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Table of Contents ( continued) page vi GLN 860.1520: Processed Food/ Feed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Apple . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Barley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Citrus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Corn, field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Cottonseed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Grape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Mint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Oats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Olive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Pineapple . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Sugarcane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Wheat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 GLN 860.1480: Meat, Milk, Poultry, and Eggs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 GLN 860.1400: Water, Fish, and Irrigated Crops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 GLN 860.1460: Food Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 GLN 860.1850 and 860.1900: Confined/ Field Accumulation in Rotational Crops . . . . . . . . . 50 TOLERANCE REASSESSMENT SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Tolerances Listed Under 40 CFR § 180.106( a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Tolerances To Be Proposed Under 40 CFR § 180.106( a) . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Tolerances Listed Under 40 CFR § 180.106( b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Tolerances To Be Proposed Under 40 CFR § 180.106( c) . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Pending Tolerance Petitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 INTERNATIONAL HARMONIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 AGENCY MEMORANDA RELEVANT TO REREGISTRATION . . . . . . . . . . . . . . . . . . . . . . . 69 MASTER RECORD IDENTIFICATION NUMBERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 DIURON REREGISTRATION ELIGIBILITY DECISION RESIDUE CHEMISTRY CONSIDERATIONS PC Code 035505; Case 0046 INTRODUCTION Diuron [ 3( 3,4 dichlorophenyl) 1,1 dimethylurea] is an herbicide currently registered for use on a variety of fruit, vegetable, nut, and field crops including alfalfa, apple, artichoke, asparagus, banana and plantain, winter barley, bermudagrass, blueberry, caneberry, citrus, red clover, field corn, cotton, filbert, gooseberry, grape, grass seed crops, macadamia nut, oats, olive, papaya, field pea, peach, pear, pecan, peppermint, pineapple, grain sorghum, sugarcane, trefoil, walnut, and winter wheat.

The reregistration of diuron is being supported by Griffin Corporation, E. I. du Pont de Nemours and Company, Drexel Chemical Company, and Aventis CropScience USA. The diuron formulation classes registered to these companies for food/ feed uses include the wettable powder ( WP), emulsifiable concentrate ( EC), dry flowable ( DF), and flowable concentrate ( FlC). These formulations are typically applied as preplant, preemergence, soil directed, or postemergence treatments using ground or aerial equipment.

REGULATORY BACKGROUND Diuron was the subject of a Reregistration Standard Guidance Document dated 9/ 83; the Residue Chemistry Science Chapter of the Guidance Document was dated 6/ 25/ 82. The Residue Chemistry Chapter Update of the Diuron Reregistration Standard was issued on 3/ 9/ 92. These documents summarized the available residue chemistry data and specified reregistration requirements in support of food/ feed uses. Several data submissions have been received and evaluated since the Update. The information contained in this document outlines the Residue Chemistry Science Assessments with respect to the reregistration of diuron. We note that although Du Pont was the primary registrant of diuron when the Update was issued, Du Pont has since transferred, cancelled, or substantially reduced its registered uses of diuron; Griffin LLC is now the primary registrant of diuron, and is taking the lead in a data sharing agreement with the other diuron registrants.

Diuron has been classified as a " known/ likely" human carcinogen by all routes.

Tolerances for residues of diuron in/ on plant and livestock commodities are established under 40 CFR § 180.106. Diuron tolerances are expressed as diuron per se. HED is now recommending that the tolerance expression for diuron be revised to include metabolites hydrolyzable to 3,4 dichloroaniline ( 3,4 DCA). This determination is based on the results of the reviewed plant and livestock metabolism 2 1. Date of the most recently EPA approved label found in the Pesticide Product Label System ( PPLS).

2. This product is a multiple active ingredient ( MAI) product, containing thidiazuron at 1 lb/ gal.

3. This product is an MAI product, containing thidiazuron at 50%.

4. This product is an MAI product, containing bromacil at 40%.

5. Including SLN LA980002.

6. Including SLN LA980003 and TX000011.

7. Including SLN OR950032. studies. Adequate residue analytical methods are available for determination of diuron total toxic residues.

GLN 860.1200: Directions for Use A search of the Agency's REFS database, conducted on 2/ 8/ 01, identified seven active diuron end use products ( EPs) registered to diuron data submitters under FIFRA Section 3 for use on food/ feed crops. These EPs, including the associated Special Local Need ( SLN) registrations under FIFRA Section 24 ( c), are listed in Table A1.

Table A1. Diuron EPs with Food/ Feed Uses Registered to Diuron Data Submitters.

EPA Reg. No. Label Acceptance Date1 Formulation Product Name Aventis CropScience USA 264 634 4/ 14/ 98 0.5 lb/ gal EC2 Ginstar ® EC Cotton Defoliant 264 661 6/ 18/ 96 25% WP3 Dropp ® Ultra Cotton Defoliant E. I. du Pont de Nemours and Co.

352 505 7/ 1/ 99 40% DF4 Krovar ® I DF Herbicide Griffin Corporation 1812 2575 3/ 15/ 01 4 lb/ gal FlC Direx 4L ® Herbicide 1812 3626 3/ 15/ 01 80% DF Karmex ® DF Herbicide Drexel Chemical Company 19713 36 3/ 15/ 01 4 lb/ gal FlC Diuron 4L Herbicide 19713 2747 11/ 30/ 00 80% WP Diuron 80 Herbicide A comprehensive summary of diuron food/ feed use patterns, based on the registered product labels of the diuron data submitters, is presented in Table A2. A tabular summary of the residue chemistry science assessments for reregistration of diuron is presented in Table B. The status of reregistration requirements for each guideline topic listed in Table B 3 is based on the use patterns registered to the members of the Diuron Task Force, the basic registrants. When end use product DCIs are developed ( e. g., at issuance of the RED), RD should require that all end use product labels ( e. g., MAI labels, SLNs, and products subject to the generic data exemption) be amended such that they are consistent with the labels of the basic registrants.

For the purpose of generating this Residue Chemistry Chapter, the Agency compared the diuron food/ feed uses currently registered to Griffin, Drexel, Du Pont, and Aventis ( Table A2) with the available crop field trial data. As a result, label amendments are required for some formulations, as specified below.

For apple, the label for the 4 lb/ gal FlC [ EPA Reg. No. 19713 36] formulation must be amended to correct an apparent typographical error. The label currently states " Apply 4 pounds per acre in the Spring;" this should be modified to state " Apply 3.2 quarts per acre in the Spring." Once corrected, the maximum application rate for apples will be 3.2 lb ai/ A, which is the maximum rate supported by available field trial data.

For banana, the labels for the 4 lb/ gal FlC [ EPA Reg. Nos. 1812 257 and 19713 36], 80% DF [ EPA Reg. No. 1812 362] and 80% WP [ EPA Reg. No. 19713 274] formulations must be modified to specify that application may only be made to bananas grown in HI.

For citrus fruits, the product labels for the 4 lb/ gal FlC [ EPA Reg. Nos. 1812 257 and 19713 36], 40% DF [ EPA Reg. No. 352 505], 80% DF [ EPA Reg. No. 1812 362] and 80% WP [ EPA Reg. No. 19713 274] formulations must be modified to specify the following maximum seasonal application rates: 6.4 lb ai/ A for FL and PR, and 3.2 lb ai/ A for all other areas.

For corn, the labels for the 4 lb/ gal FlC [ EPA Reg. Nos. 1812 257 and 19713 36], 80% DF [ EPA Reg. No. 1812 362], and 80% WP [ EPA Reg. No. 19713 274] formulations must be amended to make it clear, under the use directions for " Corn ( field)" that application is only to be made to field corn or popcorn.

For cotton, the labels for the 4 lb/ gal FlC [ EPA Reg. Nos. 1812 257 and 19713 36], 80% DF [ EPA Reg. No. 1812 362], and 80% WP [ EPA Reg. No. 19713 274] formulations must be amended to remove the maximum seasonal rate for application to cotton in loamy sand soils because the labels also state that application should not be made to loamy sand soils.

For cotton, the labels for the 25% WP [ EPA Reg. No. 264 661] and 0.5 lb/ gal EC [ EPA Reg. No. 264 634] formulations must be modified to remove the restriction against the feeding of cotton gin byproducts to livestock. The Agency does not believe that this restriction is practical.

For grass seed crops, current product labels allow application at up 3.2 lb ai/ A in the fall or up to 2.4 3.2 lb ai/ A in the spring ( depending on geographical location). No data reflecting spring application at 4 2.4 3.2 lb ai/ A are available. The registrants must modify product labels to specify a maximum application rate of 1.6 lb ai/ A for spring applications. Alternatively, crop field trial data reflecting spring application at 2.4 3.2 lb ai/ A may be submitted.

For winter wheat, the labels for the 4 lb/ gal FlC [ EPA Reg. No. 1812 257] and the 80% DF [ EPA Reg. No. 1812 362] formulations must be modified. The heading " Other Areas of Oregon and Washington" should be modified to state " Other Areas."

The products labels for EPA Reg. Nos. 19713 36 and 19713 274 include use directions for Bermudagrass. The use of diuron on Bermudagrass is not supported by field trial data or any tolerances. Tolerances for diuron residues in Bermudagrass forage and hay had previously been established; however, these tolerances were revoked in 1998. The use directions for Bermudagrass must be removed from the product labels for EPA Reg. Nos. 19713 36 and 19713 274.

SLN CA850060 is associated with EPA Reg. No. 254 247, a diuron product that was canceled in 1996. In addition, the use on SLN CA850060 is a use on lakes, ponds, holding basins, and other similar sites which may be used for irrigation. No data to support these uses are available; therefore, SLN CA850060 should be canceled.

Rotational crop restrictions should be made consistent between various formulations. A 2 year plant back interval may not be practical unless phytotoxicity is a concern.


[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27007-27009]
[FR Doc No: 2018-12448]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0155]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Veterinary Feed
Directive

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
11, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0363.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Veterinary Food Directive

OMB Control Number 0910-0363--Extension

    Section 504 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
354) establishes a regulatory category for certain new animal drugs
called veterinary feed directive (VFD) drugs. The VFD regulation is set
forth at Sec.  558.6 (21 CFR 558.6). VFD drugs are new animal drugs
intended for use in or on animal feed which are limited to use under
the professional supervision of a licensed veterinarian in the course
of the veterinarian's professional practice (Sec.  558.6(b)(6)). An
animal feed containing a VFD drug or a combination VFD drug may be fed
to animals only by or upon a lawful VFD issued by a licensed
veterinarian (Sec.  558.6(a)(1)).
    Veterinarians issue three copies of the VFD: One for their own
records, one for their client, and one to the client's VFD feed
distributor (Sec. Sec.  558.6(a)(4) and 558.6(b)(8)-(9)). The VFD
includes information about the number and species of animals to receive
feed containing one or more of the VFD drugs (Sec.  558.6(b)(3)), along
with other information required under Sec.  558.6. All distributors of
medicated feed containing VFD drugs must notify FDA

of their intent to distribute such feed and must maintain records of
the receipt and distribution of all medicated feeds containing VFD
drugs.
    The VFD regulation ensures the protection of public health while
enabling animal producers to obtain and use needed drugs as efficiently
and cost effectively as possible. The VFD regulation is tailored to the
unique circumstances relating to the distribution and use of animal
feeds containing a VFD drug.
    We use the information collected to assess compliance with the VFD
regulation. The required recordkeeping and third party disclosures
provide assurance that the medicated feeds will be safe and effective
for their labeled conditions of use and that edible products from
treated animals will be free of unsafe drug residues.
    We are retaining the estimates used in FDA's analysis of the
information collection provisions in the final rule entitled
``Veterinary Feed Directive,'' published in the Federal Register of
June 3, 2015 (80 FR 31708 at 31728), and approved by OMB.
A. Reporting Requirements
    Description of Respondents: VFD Feed Distributors and VFD Drug
Sponsors.
    A distributor of animal feed containing a VFD drug must notify FDA
prior to the first time it distributes the VFD feed (Sec.
558.6(c)(5)). This notification is required one time per distributor
and must include the information set forth in Sec.  558.6(c)(5). In
addition, a distributor must notify FDA within 30 days of any change in
ownership, business name, or business address (Sec.  558.6(c)(6)).
Additional reporting burdens for current VFD drug sponsors are approved
under OMB control numbers 0910-0032 (New Animal Drug Applications) and
0910-0669 (Abbreviated New Animal Drug Applications).

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           21 CFR section/activity               Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(c)(5) requires a distributor to notify             300               1             300  0.125 (7 minutes).........................            37.5
 FDA prior to the first time it distributes
 a VFD feed.
558.6(c)(6) requires a distributor to notify              20               1              20  0.125 (7 minutes).........................             2.5
 FDA within 30 days of any change in
 ownership, business name, or business
 address.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................              40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

B. Recordkeeping Requirements
    Description of Respondents: VFD Feed Distributors, Food Animal
Veterinarians, and Clients (Food Animal Producers).
    As stated previously, veterinarians issue three copies of the VFD:
One for their own records, one for their client, and one to the
client's VFD feed distributor. All involved parties (veterinarian,
distributor, and client) must retain a copy of the VFD for 2 years
(Sec.  558.6(a)(4)). In addition, VFD feed distributors must also keep
receipt and distribution records of VFD feeds they manufacture and make
them available for inspection by FDA for 2 years (Sec.  558.6(c)(3)).
If a distributor manufactures the VFD feed, the distributor must also
keep VFD manufacturing records for 1 year in accordance with 21 CFR
part 225 and such records must be made available for inspection and
copying by FDA upon request (Sec.  558.6(c)(4)). These record
requirements are currently approved under OMB control number 0910-0152,
``Current Good Manufacturing Practice Regulations for Medicated Feed.''
Distributors may distribute VFD feeds to another distributor only if
the originating distributor first obtains a written acknowledgement
letter. Such letters, like VFDs, are also subject to a 2-year record
retention requirement (Sec.  558.6(c)(8)).

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           21 CFR section/activity               Number of     responses per   Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(a)(4); required recordkeeping by                13,050           114.9       1,500,000  0.0167 (1 minute).........................          25,050
 veterinarians and producers.
558.6(a)(4), (c)(3), (c)(4), and (c)(8);               1,376           545.1         750,000  0.0167 (1 minute).........................          12,525
 required recordkeeping by distributors.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          37,575
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

C. Third-Party Disclosure Requirements
    Description of Respondents: VFD Drug Sponsors, Food Animal
Veterinarians, VFD Feed Distributors, and Clients.
    FDA regulation requires that veterinarians include the information
specified at Sec.  558.6(b)(3) through (5) on the VFD. Additional
requirements relating to the VFD are specified at Sec.  558.6(b)(7)
through (9). A distributor may only distribute a VFD feed to another
distributor for further distribution if the originating distributor
(consignor) first obtains a written acknowledgement letter from the
receiving distributor (consignee) before the feed is shipped (Sec.
558.6(c)(8)).

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           21 CFR section/activity               Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(b)(3)-(b)(5) and (b)(7)-(b)(9);                  3,050             246         750,000  0.125 (7 minutes).........................          93,750
 required disclosures when a veterinarian
 issues a VFD.
558.6(c)(8); required disclosure                       1,000               5           5,000  0.125 (7 minutes).........................             625
 (acknowledgement letter) from one
 distributor to another.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          94,375
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The VFD regulation also contains several labeling provisions that
are exempt from OMB review and approval under the PRA because they are
a ``public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)) and therefore do not constitute a
``collection of information'' under the PRA (44 U.S.C. 3501, et seq.).
All labeling and advertising for VFD drugs, combination VFD drugs, and
feeds containing VFD drugs or combination VFD drugs must prominently
and conspicuously display the following cautionary statement:
``Caution: Federal law restricts medicated feed containing this
veterinary feed directive (VFD) drug to use by or on the order of a
licensed veterinarian'' (Sec.  558.6(a)(6)). In addition, the
veterinarian must ensure that the following statement is included on
the VFD (Sec.  558.6(b)(3)(xiii)): ``Use of feed containing this
veterinary feed directive (VFD) drug in a manner other than as directed
on the labeling (extralabel use) is not permitted.''
    The veterinarian may restrict VFD authorization to only include the
VFD drug(s) cited on the VFD or such authorization may be expanded to
allow the use of the cited VFD drug(s) along with one or more over-the-
counter animal drugs in an approved, conditionally approved, or indexed
combination VFD drug (Sec.  558.6(b)(6)). The veterinarian must affirm
his or her intent regarding combination VFD drugs by including one of
the following statements on the VFD:
    1. ``This VFD only authorizes the use of the VFD drug(s) cited in
this order and is not intended to authorize the use of such drug(s) in
combination with any other animal drugs'' (Sec.  558.6(b)(6)(i)).
    2. ``This VFD authorizes the use of the VFD drug(s) cited in this
order in the following FDA-approved, conditionally approved, or indexed
combination(s) in medicated feed that contains the VFD drug(s) as a
component.'' (List specific approved, conditionally approved, or
indexed combination medicated feeds following this statement.) (Sec.
558.6(b)(6)(ii)).
    3. ``This VFD authorizes the use of the VFD drug(s) cited in this
order in any FDA-approved, conditionally approved, or indexed
combination(s) in medicated feed that contains the VFD drug(s) as a
component'' (Sec.  558.6(b)(6)(iii)).
    These labeling statements are not subject to review by OMB because,
as stated previously, they are a ``public disclosure of information
originally supplied by the Federal government to the recipient for the
purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)) and
therefore do not constitute a ``collection of information'' under the
PRA (44 U.S.C. 3501, et seq.).
    The one-time burdens included in FDA's analysis of the June 3,
2015, final rule (80 FR 31708 at 31729 to 31732) are not included in
the estimate provided in this notice. FDA's estimate of the annual
recurring burden for this information collection has not changed since
the last OMB approval.

    Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12448 Filed 6-8-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Proposed Rules]
[Pages 28035-28037]
[FR Doc No: 2016-10799]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 11, 16, and 111

[Docket No. FDA-2015-N-0797]

The Food and Drug Administration Food Safety Modernization Act:
Focus on Strategic Implementation of Prevention-Oriented Import Safety
Programs; Public Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meetings.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
three one-day public meetings in different regions throughout the
United States to provide importers and other interested persons an
opportunity to have an in-depth discussion on the implementation of the
FDA Food Safety Modernization Act (FSMA) import safety programs (i.e.,
foreign supplier verification programs (FSVPs) for importers of food
for humans and animals, accreditation of third-party certification
bodies, and FDA's Voluntary Qualified Importer Program (VQIP)). During
these meetings, participants and key FDA subject matter experts will
discuss the next phase of FSMA implementation related to import safety
programs, which includes establishing the operational framework for
these programs and plans for guidance documents, training, education,
and technical assistance. The purpose of the regional outreach public
meetings is to continue the dialogue with the importer community on
FSMA and elicit ideas that will help to inform FDA and our stakeholders
on how to continue to work together to successfully comply with FSMA
mandates and regulations.

DATES: See section III for dates and times of the regional outreach
meetings, closing dates for advance registration, and requests for
special accommodations due to disability.

ADDRESSES: See section III for meeting locations.

FOR FURTHER INFORMATION CONTACT:

    For questions about registering for the meeting, or to register by
phone: Peggy Walker, Planning Professionals Ltd., 1210 West McDermott
St., Suite 111, Allen, TX 75013,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>    For general questions about the meeting or for special
accommodations due to a disability: Juanita Yates, Center for Food
Safety and Applied Nutrition (HFS-009), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On May 2, 2014, we released our ``Operational Strategy for
Implementing the FDA Food Safety Modernization Act (FSMA),''
electronically at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm, to guide the next phase of FSMA implementation following
the establishment of regulations and relevant programs. Within the
``Operational Strategy for Implementing FSMA,'' there is an appendix
that outlines guiding principles for how the operational strategy can
be implemented with respect to food and feed facilities, produce safety
standards, and import oversight. The guiding principles include the
following: Expanding inspection and surveillance; administering new
administrative enforcement tools; developing guidance, education, and
technical assistance tools; and building a prevention-oriented import
system.
    On April 23, 2015, FDA hosted a public meeting as an opportunity
for interested persons to share views concerning how FDA should address
the operational aspects of FSMA implementation as suggested by the
guiding principles. We provided an update on current planning efforts
and received input from the public to inform the development of
operational work plans in the areas of produce safety, preventive
controls for foods for humans and animals, measures to address
intentional adulteration, FSVP, and the FDA third-party accreditation
program. In addition, we established a docket to obtain comments on a
range of operational issues that we might consider in our FSMA
implementation approach.
    On March 21, 2016, FDA hosted a kick-off public meeting to brief
participants on the key components of the FSVP and third-party
certification final rules; brief participants on the status of the
VQIP; discuss the plans for guidance documents related to import
safety, as well as training, education, and technical assistance;
provide an update on the development of a risk-based industry oversight
framework that is at the core of FSMA; and answer questions about these
import programs. The public meeting was an opportunity for FDA to share
its current thinking on implementation plans for programs related to
import safety. During that public meeting, we mentioned plans to
continue dialogue on implementation of these import safety programs
with a series of regional meeting across the United States.
    The agendas, recordings, and transcripts for the FSMA
implementation and prevention-oriented import system public meetings
are accessible on our FSMA Web site at http://www.fda.gov/FSMA.

II. Purpose and Format of the Regional Outreach Meetings

    FDA plans to hold three one-day public meetings in different
regions throughout the United States to provide importers and other
interested persons an opportunity to have an in-depth discussion on the
implementation of FSMA import safety programs (i.e., FSVPs for
importers of food for humans and animals, accreditation of third-party
certification bodies, and FDA's VQIP). We invite the public to provide
information, share experiences, and raise issues on implementation
topics related to import safety including (but not limited to):
Increasing awareness/reaching the regulated community, potential
partners on outreach and implementation, state of readiness, barriers
to implementation, training and education for industry and regulators,
guidance needs, promotion of best practices, technical assistance,
compliance and enforcement issues, and long-term implementation
success. The purpose of the regional outreach meetings is to continue
the dialogue with the importer community and elicit ideas that will
help to inform FDA and the regulated population on how to continue to
work together to successfully comply with FSMA mandates and
regulations.

III. How To Participate in the Public Meeting

    We are holding three one-day public meetings in different regions
throughout the United States.
    Due to limited space and time, we encourage all persons who wish to
attend the meeting to register in advance. There is no fee to register
for the regional outreach meetings, and registration will be on a
first-come, first-served basis. Early registration is recommended
because seating is very limited.
    Table 1 provides information on participation in the regional
outreach meetings.

                                                  Table 1--Information on Participation in the Meeting
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Special
   Regional outreach meetings           Date               Address          Preregister       Electronic address      accommodations   Other information
--------------------------------------------------------------------------------------------------------------------------------------------------------
California Regional Outreach     June 7, 2016, from  The Hilton Costa    May 26, 2016:      Please preregister at   May 25, 2016:      Registration
 Meeting.                         8:30 a.m. to 3      Mesa, 3050          Closing date for   http://www.fda.gov/     Closing date to    check-in begins
                                  p.m. PDT.           Bristol Street,     Registration.      Food/NewsEvents/        request special    at 8 a.m.
                                                      Costa Mesa, CA                         WorkshopsMeetingsConf   accommodations
                                                      92626.                                 erences/default.htm.    due to a
                                                                                disability.
New Jersey Regional Outreach     June 15, 2016,      Renaissance         June 3, 2016:      Please preregister at   June 2, 2016:      Registration
 Meeting.                         from 8:30 a.m. to   Meadowlands         Closing date for   http://www.fda.gov/     Closing date to    check-in begins
                                  3 p.m. EDT.         Hotel, 801          Registration.      Food/NewsEvents/        request special    at 8 a.m.
                                                      Rutherford                             WorkshopsMeetingsConf   accommodations
                                                      Avenue,                                erences/default.htm.    due to a
                                                      Rutherford, NJ                                                 disability.
                                                      07070.

Michigan Regional Outreach       June 21, 2016,      Double Tree Suites  June 10, 2016:     Please preregister at   June 9, 2016:      Registration
 Meeting.                         from 8:30 a.m. to   by Hilton Hotel     Closing date for   http://www.fda.gov/     Closing date to    check-in begins
                                  3 p.m. EDT.         Detroit_Downtown   Registration.      Food/NewsEvents/        request special    at 8 a.m.
                                                      Fort Shelby, 525                       WorkshopsMeetingsConf   accommodations
                                                      W Lafayette                            erences/default.htm.    due to a
                                                      Blvd., Detroit,                                                disability.
                                                      MI 48226.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your registration
  information and send to: Peggy Walker, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013,<PHONE_NUMBER>, FAX: 469-854-
  6992, email<EMAIL_ADDRESS>

    Dated: May 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10799 Filed 5-6-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 10, 2009 (Volume 74, Number 236)]
[Notices]
[Page 65553-65554]
[DOCID:fr10de09-87]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 3a-4; SEC File No. 270-401; OMB Control No. 3235-0459.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Rule 3a-4 (17 CFR 270.3a-4) under the Investment Company Act of
1940 (15 U.S.C. 80a) (``Investment Company Act'' or ``Act'') provides a
nonexclusive safe harbor from the definition of investment company
under the Act for certain investment advisory programs. These programs,
which include ``wrap fee'' and ``mutual fund wrap'' programs, generally
are designed to provide professional portfolio management services to
clients who are investing less than the minimum usually required by
portfolio managers but more than the minimum account size of most
mutual funds. Under wrap fee and similar programs, a client's account
is typically managed on a discretionary basis according to pre-selected
investment objectives. Clients with similar investment objectives often
receive the same investment advice and may hold the same or
substantially similar securities in their accounts. Some of these
investment advisory programs may meet the definition of investment
company under the Act because of the similarity of account management.
    In 1997, the Commission adopted rule 3a-4, which clarifies that
programs organized and operated in a manner consistent with the
conditions of rule 3a-4 are not required to register under the
Investment Company Act or comply with the Act's requirements.\1\ These
programs differ from investment companies because, among other things,
they provide individualized investment advice to the client. The rule's
provisions have the effect of ensuring that clients in a program
relying on the rule receive advice tailored to the client's needs.
---------------------------------------------------------------------------

    \1\ Status of Investment Advisory Programs Under the Investment
Company Act of 1940, Investment Company Act Release No. 22579 (Mar.
24, 1997) (62 FR 15098 (Mar. 31,1997)) (``Adopting Release''). In
addition, there are no registration requirements under section 5 of
the Securities Act of 1933 for these programs. See 17 CFR 270.3a-4,
introductory note.
---------------------------------------------------------------------------

    Rule 3a-4 provides that each client's account must be managed on
the basis of the client's financial situation and investment objectives
and consistent with any reasonable restrictions the client imposes on
managing the account. When an account is opened, the sponsor \2\ (or
its designee) must obtain information from each client regarding the
client's financial situation and investment objectives, and must allow
the client an opportunity to impose reasonable restrictions on managing
the account.\3\ In addition, the sponsor (or its designee) must contact
the client annually to determine whether the client's financial
situation or investment objectives have changed and whether the client
wishes to impose any reasonable restrictions on the management of the
account or reasonably modify existing restrictions. The sponsor (or its
designee) must also notify the client quarterly, in writing, to contact
the sponsor (or its designee) regarding changes to the client's
financial situation, investment objectives, or restrictions on the
account's management.\4\
---------------------------------------------------------------------------

    \2\ For purposes of rule 3a-4, the term ``sponsor'' refers to
any person who receives compensation for sponsoring, organizing or
administering the program, or for selecting, or providing advice to
clients regarding the selection of, persons responsible for managing
the client's account in the program.
    \3\ Clients specifically must be allowed to designate securities
that should not be purchased for the account or that should be sold
if held in the account. The rule does not require that a client be
able to require particular securities be purchased for the account.
    \4\ The sponsor also must provide a means by which clients can
contact the sponsor (or its designee).
---------------------------------------------------------------------------

    The program must provide each client with a quarterly statement
describing all activity in the client's account during the previous
quarter. The sponsor and personnel of the client's account manager who
know about the client's account and its management must be reasonably
available to consult with the client. Each client also must retain
certain indicia of ownership of all securities and funds in the
account.
    The requirement that the sponsor (or its designee) obtain
information about each new client's financial situation and investment
objectives when their account is opened is designed to ensure that the
investment adviser has sufficient information regarding the client's
unique needs and goals to

enable the portfolio manager to provide individualized investment
advice. The sponsor is required to contact clients annually and provide
them with quarterly notices to ensure that the sponsor has current
information about the client's financial status, investment objectives,
and restrictions on management of the account. Maintaining current
information enables the portfolio manager to evaluate each client's
portfolio in light of the client's changing needs and circumstances.
The requirement that clients be provided with quarterly statements of
account activity is designed to ensure each client receives an
individualized report, which the Commission believes is a key element
of individualized advisory services.
    The Commission staff estimates that 3,109,671 clients participate
each year in investment advisory programs relying on rule 3a-4. Of that
number, the staff estimates that 220,805 are new clients and 2,888,866
are continuing clients. The staff estimates that each year investment
advisory program sponsors staff engage in 1.5 hours per new client and
0.75 hours per continuing client to prepare, conduct and/or review
interviews regarding the client's financial situation and investment
objectives as required by the rule. Furthermore, the staff estimates
that each year investment advisory program staff spends 1 hour per
client to prepare and mail quarterly client account statements,
including notices to update information. Based on the estimates above,
the Commission estimates that the total annual burden of the rule's
paperwork requirements is 5,607,528 hours.
    The total annual hour burden of 5,607,528 hours represents an
increase of 1,158,112.5 hours from the prior estimate of 4,449,415.5
hours. This increase principally results from an increase in the number
of continuing clients, but also reflects an increase in the estimated
burden hours associated with several of the collections of information
required under the rule. The increase in estimated burden hours per
collection of information results from an increase in burden hours
reported by representatives of investment advisers that rely on rule
3a-4 that Commission staff surveyed.
    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act. The estimate is not derived
from a comprehensive or even a representative survey or study of the
costs of Commission rules and forms. An agency may not conduct or
sponsor, and a person is not rquired to respond to a collection of
information unless it displays a currenly valid control number.
    Written comments are invited on: (a) Whether the collections of
information are necessary for the proper performance of the functions
of the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burdens
of the collections of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burdens of the collections of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to Charles Boucher, Director/
CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432
General Green Way, Alexandria, VA 22312; or send an e-mail to: PRA_
<EMAIL_ADDRESS>
    December 4, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-29393 Filed 12-9-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 128 (Tuesday, July 5, 2016)]
[Notices]
[Page 43627]
[FR Doc No: 2016-15814]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4255-DR; Docket ID FEMA-2016-0001]

Texas; Amendment No. 2 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for State of Texas (FEMA-4255-DR), dated February 9, 2016, and related
determinations.

DATES: Effective Date: May 23, 2016.

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: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, William J.
Doran III, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Kevin L. Hannes as
Federal Coordinating Officer for this disaster.

    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.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-15814 Filed 7-1-16; 8:45 am]
 BILLING CODE 9111-23-P


Recordkeeping The number of notification events per entity is the sum of pre course, post course, and renotifications submitted by training providers, and the sum of pre abatement and re notifications submitted by firms. The sources of this information are discussed in detail in the respective training provider and firm sections of this analysis. The EPA recordkeeping burden per notification event is estimated at 0.11 hours for training providers and 0.09 hours for abatement firms. Both estimates were obtained by contacting two State agencies, which currently operate similar lead based paint training programs, and maintain lead based paint activity notification records in both electronic and hard copy forms. The number of entities administered by the EPA program was estimated in section 6( a) of this analysis.

Annual Burden As presented below in Exhibit 6.19., this analysis estimates the notification recordkeeping burden for EPA in the year 2004/ 05 to be 1,846 hours. The notification recordkeeping burden for EPA is estimated to rise slightly to 2,006 hours during the year 2005/ 06, and then rise slightly again to 2,169 in 2006/ 07. 61 Exhibit 6.19. EPA: Notification Burden Estimates Category Notifications per Entity Clerical Hours/ Notification 2004/ 05 2005/ 06 2006/ 07 Firms 15.36 15.36 15.36 0.09 Training Providers 4.51 4.91 4.45 0.11 Entities per Year 2004/ 05 2005/ 06 2006/ 07 Firms 19,308 21,151 22,871 Training Providers 218 188 226 Burden Hours per Year 2004/ 05 2005/ 06 2006/ 07 Firms 1,738 1,904 2,058 Training Providers 108 102 111 Total Burden 1,846 2,006 2,169 Agency Cost The notification costs are based on the burden estimated in Section 6( a) and the EPA Regional clerical wage rate estimated earlier. The final loaded wage rate is $ 22.82 for EPA Regional clerical staff.

Annual Cost As presented below in Exhibit 6.20., this analysis estimates the EPA cost associated with notifications in the year 2004/ 05 to be $ 42,123. That cost is expected to rise slightly to $ 45,757 in 2005/ 06, and then rise slightly again to $ 49,498 in 2006/ 07.

Exhibit 6.20. EPA: Notification Cost Estimates Category Notifications per Entity Clerical Cost/ Notification ($ 22.82/ hr) 2004/ 05 2005/ 06 2006/ 07 Firms 15.36 15.36 15.36 $ 2.05 Training Providers 4.51 4.91 4.45 $ 2.51 Entities per Year 2004/ 05 2005/ 06 2006/ 07 Firms 19,308 21,151 22,871 Training Providers 218 188 226 Cost per Year 2004/ 05 2005/ 06 2006/ 07 Firms $ 39,655 $ 43,440 $ 46,973 Training Providers $ 2,468 $ 2,317 $ 2,525 Total Annual Cost $ 42,123 $ 45,757 $ 49,498 62 6( d) Bottom Line Burden Hours and Cost ( i) Respondent Tally Respondent Burden and Cost Accreditation and Certification Burden and Cost 2004/ 05 2005/ 06 2006/ 07 Burden Hours Costs Burden Hours Costs Burden Hours Costs Training Providers 1,329 $ 53,973 1,116 $ 45,152 1,654 $ 68,024 Firms Performing Lead based Paint Activities 351,764 $ 12,607,247 361,118 $ 12,944,692 369,530 $ 13,244,825 Individuals 7,026 $ 227,618 7,022 $ 227,490 7,088 $ 229,633 States 48,813 $ 1,858,856 48,813 $ 1,858,856 48,813 $ 1,858,856 Total 408,932 $ 14,747,694 418,069 $ 15,076,190 427,085 $ 15,401,338 Notification Burden and Cost 2004/ 05 2005/ 06 2006/ 07 Burden Hours Costs Burden Hours Costs Burden Hours Costs Training Providers 1,351 $ 32,936 1,350 $ 32,893 1,361 $ 33,194 Firms Performing Lead based Paint Activities 16,284 $ 428,516 16,709 $ 429,373 17,104 $ 439,505 States 4,730 $ 107,944 4,736 $ 108,092 4,729 $ 107,922 Total 22,365 $ 569,396 22,795 $ 570,358 23,194 $ 580,621 Over All Total 431,297 $ 15,317,090 440,864 $ 15,646,548 450,279 $ 15,981,959 The respondent burden and cost for the collection of this information in the year 2004/ 2005 is estimated to be 2,680 hours and $ 86,909 for the estimated 365 training providers; 368,048 hours and $ 13,055,763 for the estimated 4,626 firms performing lead based paint activities; 7,026 hours and $ 227,618 for the 18,269 individual lead abatement personnel; and 53,543 hours and $ 1,966,800 for the States. That is an average burden of 7.34 hours per training provider, 79.56 hours per certified firm, and 0.38 hours per certified individual. The overall burden and cost for this year for all respondents is 431,297 hours and $ 15,317,090.

The respondent burden and cost for the collection of this information in the year 2005/ 2006 is estimated to be 2,466 hours and $ 78,045 for the estimated 335 training providers; 377,827 hours and $ 13,374,065 for the estimated 4,746 firms performing lead based paint activities; 7,022 hours and $ 227,490 for the 18,293 individual lead abatement personnel; and 53,543 hours and $ 1,966,948 for the States. That is an average burden of 7.36 hours per training provider, 79.61 hours per certified firm, and 0.38 hours per certified individual. The overall burden and cost for this year for all respondents is 440,864 hours and $ 15,646,548.

The respondent burden and cost for the collection of this information in the year 2006/ 2007 is estimated to be 3,015 hours and $ 101,218 for the estimated 373 training providers; 386,634 hours 63 and $ 13,684,330 for the estimated 4,858 firms performing lead based paint activities; 7,088 hours and $ 229,633 for the 18,308 individual lead abatement personnel; and 53,543 hours and $ 1,966,778 for the States. That is an average burden of 8.08 hours per training provider, 79.59 hours per certified firm, and 0.39 hours per certified individual. The overall burden and cost for this year for all respondents is 450,279 hours and $ 15,981,959.

The average overall annualized burden and cost for the three years covered by this ICR for all respondents is 440,813 hours and $ 15,648,532.

( ii) Agency Tally Agency Burden and Cost EPA Accreditation and Certification Burden and Cost 2004/ 2005 2005/ 2006 2006/ 2007 Burden Hours Costs Burden Hours Costs Burden Hours Costs Regions 6,509 $ 598,864 7,230 $ 629,842 9,437 $ 721,877 Headquarters 728 $ 28,501 728 $ 28,501 728 $ 28,501 Total 7,237 $ 627,365 7,958 $ 658,343 10,165 $ 750,378 EPA Notification Burden and Cost 2004/ 2005 2005/ 2006 2006/ 2007 Burden Hours Costs Burden Hours Costs Burden Hours Costs 1,846 $ 42,123 2,006 $ 45,757 2,169 $ 49,498 Over All Totals 9,083 $ 669,488 9,964 $ 704,100 12,334 $ 799,876 The Agency burden and cost for the collection of this information is estimated to be 9,083 hours and $ 669,488 in the year 2004/ 2005; 9,964 hours and $ 704,100 in 2005/ 2006; and 12,334 hours and $ 799,826 in 2006/ 2007.

The average overall annualized burden and cost for the Agency for the three years covered by this ICR is 10,460 hours and $ 724,488.

6( e) Reasons for Change in Burden This request reflects an increase in the total estimated burden of 49,639 hours ( from 391,174 hours to 440,813 hours) from that currently in the OMB inventory. This increase represents an adjustment in the number of respondents and/ or the number of activities or events for which respondents must provide information, based on EPA's experience since the approval of the most recent ICR.

The burden in this ICR covers the activities that were reported in two previous ICRs. In this section the Accreditation and Certification portions of this ICR will be compared to those same activities as reported in 1999. Then a comparison will be made between the Notification portions of this ICR and an earlier ICR that covered those same activities. 64 Accreditation and Certification The previous ICR covering Accreditation and Certification activities was developed before data on the numbers of activities were available, and relied on burden estimates developed in the TSCA 402/ 404 Regulatory Impact Analysis and experience with other similar rules, such as the Asbestos MAP. Data are now available on the level of activities under EPA administration, permitting a more direct projection of activities over the period of this ICR.

It is difficult to directly compare the burden projected by the previous ICR and this one, since the previous ICR projected extreme year to year variability in the accreditation and certification activity projected in the previous ICR. That variability was due to the expected high level of activity at the beginning of the program caused by the initial wave of accreditation and certification. However, it is possible to make comparisons to the average burdens and also to look at specific elements that determine burden.

Comparison of Average Annual Burden Estimates over Three Years, Accreditation and Certification Only, 1991 and 2004 ICRs Burden Hours Percent Increase Absolute Increase Share of Increase 1999 ICR 2004 ICR Training providers 742 1,366 84 % 624 1.3 %

Certified firms 317,328 360,804 14 % 43,476 92.9 %

Certified individuals 7,216 7,045  2 %  171  0.4 %

States 45,928 48,813 6 % 2,885 6.2 %

Total 371,214 418,029 13 % 46,814 The largest share of the burden increase, about 93%, is in the burden on certified firms. The estimates of burden per firm are the same in this ICR as in the previous one. This ICR estimates that there will be about 1,375 certified firms on average in EPA administered areas, and an average of 3,370 in non EPA areas, for a total of 4,745. The previous ICR projected 1,170 firms in EPAadministered areas and 2,900 in non EPA areas, for a total of about 4,070. That is an increase of about 16 percent. The percentage burden increase in burden hours was a bit smaller at 13 percent. This minor discrepancy was probably due to the reduction in the numbers of first time certifications after the initial wave associated with the program start up. Except for that small discrepancy, the increase in the total burden on firms is due to a larger estimate of the number of firms engaged in abatement activities.

The burden on training providers is a small part of the overall burden, but it went up by a substantial percentage. This is due to the fact that first time accreditations of training providers are running at a higher rate in the EPA administered areas than had been anticipated. 65 The burden on States has gone up about 6 percent. This increase is primarily due to the increase in the number of approved State and Tribal administered programs. The previous ICR was based on an assumption of 32 approved State programs. This ICR is based on the 39 State programs that were projected to be approved by the fifth year of this ICR, as projected in the Fees Rule EA. This is a close match to the 39 States and three Tribes that have been authorized as of January 2004.

The average annual cost of this burden is about $ 15 million, in comparison to the $ 12 million average annual cost estimated in the previous ICR. That represents an increase of 25 percent. This is due to the 13 percent increase in burden hours along with the increase in hourly labor costs.

Notification The notification portion of this ICR estimates that the burden on training providers, firms, and States will be roughly 22,000 to 23,000 hours per year. The previous ICR estimated a burden of about 18,000 to 20,000 hours per year. Therefore the estimated total burden for these activities is about 3,000 to 4,000 hours more per year than the earlier ICR. Since the burden per activity or event was assumed to be the same in both ICRs, this difference is due to a higher estimate of the number of expected activities or events. This difference is in turn due to the method used to estimate the frequency of activities. The earlier ICR was based on projections made prior to the start of any of these activities. The estimates in this ICR are based at least in part on the data on activities that EPA has accumulated over the past five years.

6( f) Burden Statement The annual public burden for this collection of information, which is approved under OMB Control No. 2070 0155, is estimated to range between 0.4 hours and 79.6 hours per response, depending on the type of respondent. According to the Paperwork Reduction Act, " burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OPPT 2004 0081, which is available for public viewing at the Pollution Prevention and Toxics 66 Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1544 and the telephone number for the Pollution Prevention and Toxics Docket is ( 202) 566 0280. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. OPPT 2004 0081 and OMB control number 2070 0155 in any correspondence.