Title: Gypsy Moth Identification.

OMB Number: 0579-0104.

Type of Request: Extension of approval of an information collection.

Abstract: The United States Department of Agriculture (USDA) is responsible for, among other things, the control and eradication of plant pests. The Plant Protection Act authorizes the Department to carry out this mission.

To this end, Plant Protection and Quarantine (PPQ) of the Animal and Plant Health Inspection Service (APHIS), USDA, engages in detection surveys to monitor for the presence of, among other things, the European gypsy moth and the Asian gypsy moth.

The European gypsy moth was introduced into the United States in the 1860's and has been damaging woodland areas in the Northeast for the last 100 years. The Asian gypsy moth, which is not established in this country, is considered to pose an even greater threat to trees and forested areas.

Unlike the flightless European gypsy moth female adult, the Asian gypsy moth female adult is capable of strong directed flight between mating and egg deposition, significantly increasing its ability to spread over a much greater area and become widely established within a short time.

To determine the presence and extent of a European gypsy moth or an Asian gypsy moth infestation, we set traps in high-risk areas to collect specimens. Once an infestation is identified, control and eradication work (usually involving State cooperation) is initiated to eliminate the moths.

APHIS personnel, with assistance from State agriculture personnel, check traps for the presence of gypsy moths. If a suspicious moth is found in the trap, it is sent to APHIS laboratories at the Otis Methods Development Center in Michigan so that it can be correctly identified through DNA analysis. (Since the European gypsy moth and the Asian gypsy moth are strains of the same species, they cannot be visually distinguished from each other. DNA analysis is the only way to accurately identify these insects.)

The PPQ or State employee submitting the moth for analysis completes a gypsy moth identification worksheet (PPQ Form 305), which accompanies the insect to the laboratory. The worksheet enables both Federal and State regulatory officials to identify and track specific specimens through the DNA identification tests that we conduct.

The information provided by the gypsy moth identification worksheets is vital to our ability to monitor, detect, and eradicate gypsy moth infestations.

We are asking the Office of Management and Budget (OMB) to approve our use of this information collection activity for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the information collection on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies, e.g., permitting electronic submission of responses.

Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.083 hours per response.

Respondents: State cooperators.

Estimated annual number of respondents: 120.

Estimated annual number of responses per respondent: 2.

Estimated annual number of responses: 240.

Estimated total annual burden on respondents: 20 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

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.

As part of an integrated control project to reduce the severity of Melaleuca quinquenervia (Cav.) S.T. Blake (Myrtales: Myrtaceae) infestations in Florida, the Animal and Plant Health Inspection Service (APHIS) is proposing to release two nonindigenous organisms, Boreioglycaspis melaleucae Moore (Hemiptera: Psyllidae) and Lophyrotoma zonalis Rohwer (Hymenoptera: Pergidae) in areas affected by melaleuca.

Melaleuca, a broad-leaf paper bark tree native to Australia, was originally introduced in Florida during the early 1900's as an ornamental and was later planted along dikes and levees for erosion control and to convert wetlands into productive forest lands. Over the last four decades, it has spread throughout southern Florida, displacing native plant and animal species, and threatening the stability of the Florida Everglades ecosystem. The purpose of the proposed action is to reduce the severity of the infestations of melaleuca throughout the affected areas.

APHIS' current melaleuca control project encompasses the areas known to be infested in central and south Florida and involves an integrated control approach sensitive to site-specific conditions, which may include a combination of physical, biological, and/or chemical controls. In response to permit applications the Agency received for the release of B. melaleucae , a psyllid native to Australia, and L. zonalis , a sawfly also native to Australia, APHIS is investigating the use of these biological control agents to control melaleuca in the affected areas. If APHIS decides to issue permits to release B. melaleucae and/or L. zonalis , these organisms would be added to the integrated control methods already available. Presently, there is only one biological control agent, a nonindigenous weevil ( Oxyops vitiosa ), used to suppress melaleuca.

APHIS has completed an environmental assessment that considers the effects of, and alternatives to, releasing B. melaleucae and L. zonalis into the environment. B. melaleucae and L. zonalis are known to attack only species within the family Myrtaceae. Our findings indicate that L. zonalis and B. melaleucae will not develop on any native species of Myrtaceae, but may temporarily feed on, and cause minor damage to, introduced species of Callistemon and Myrtaceae, and possibly wax myrtle. There is no evidence that the release of these two biological control agents will adversely affect threatened and endangered species or their habitat, or cultural, historical, and archaeological resources.

L. zonalis is being tested for toxicity to vertebrates because a closely related species, Lophyrotoma interrupta Klug, is reported to be toxic to cattle in Australia under certain conditions. Until further testing is completed, L. zonalis will not be released into the environment. Therefore, we are considering the release of B. melaleucae and, pending further testing, the release of L. zonalis to reduce the severity of melaleuca infestations in Florida.

APHIS' review and analysis of the potential environmental impacts associated with releasing these biological control agents into the environment are documented in detail in an environmental assessment entitled “Field Release of Two Biological Control Agents Boreioglycaspis melaleucae Moore (Hemiptera: Psyllidae) and Lophyrotoma zonalis Rohwer (Hymenoptera: Pergidae) for the Control of Melaleuca quinquenervia (Cav.) S.T. Blake (Myrtales: Myrtaceae) in South Florida” (September 2001). We are making this environmental assessment available to the public for review and comment.

The environmental assessment may be viewed on the Internet at http://www.aphis.usda.gov/ppq/ by accessing “Forms,” then “Permits-Pests;” the environmental assessment is document number 0030. Copies of the environmental assessment may be obtained by calling the Plant Protection and Quarantine Automated Fax System at (301) 734-4327 or (301) 734-3560; please enter document number 0030 when prompted. You may also request copies of the environmental assessment by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT . Please refer to the title of the environmental assessment when requesting copies. The environmental assessment is also available for review in our reading room (information on the location and hours of the reading room is listed under the heading ADDRESSES at the beginning of this notice.)

The environmental assessment has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

Title: Nutrition Education Materials for FNS Population Groups.

OMB Number: Not yet assigned.

Expiration Date: N/A.

Type of Request: New collection.

Abstract: Diet has a significant impact on the health of citizens and is linked to four leading causes of disease and premature death. Diet also plays a role in the development of other health conditions, which can reduce the quality of life and contribute to premature death. One of FNS' goals includes improving the nutrition of children and low-income families by providing access to program benefits and nutrition education in a manner that supports American agriculture and inspires public confidence.

Materials in support of nutrition education goals will be developed by FNS. Eat Smart. Play Hard. TM (ESPH) is a project geared particularly towards children, including their caregivers, who are eligible for FNS nutrition assistance programs. Components already completed for ESPH consist of a spokes character with accompanying posters, brochures, activity sheets, and a kit of promotional materials.

As part of the Phase II development of ESPH, FNS will develop the following:

1. Additional messages and materials for a subsection of the children and caregivers group, materials for Hispanic children and caregivers as well as public service announcements (PSA's); and

2. An interactive Internet Web site.

In addition to ESPH Phase II, FNS will also develop materials to include:

1. Low-literacy education materials and tools to communicate and promote the implementation of the Dietary Guidelines for Americans; and

2. The conversion of existing English nutrition education materials to appropriate language and culture for the Hispanic audiences.

The materials will be tested using focus groups, short semi-structured interviews, and web-based tools to test the interactive Web site. The groups tested will provide information regarding the acceptability of materials and products during both the developmental process and during the final product development stage. Semi-structured short interviews will be conducted with FNS program recipients, staff, stakeholders and consumer volunteers at the State and local levels to determine acceptability and efficacy of materials and products developed. Interviews will be integrated into other program activities as appropriate.

FNS will also collect information regarding effective nutrition education initiatives being implemented by State agencies that administer nutrition assistance programs to address critical nutrition issues.

Respondents: Recipients of and those persons eligible for FNS nutrition assistance programs, State and local staff administering FNS programs, FNS stakeholders and consumers.

Estimated Number of Respondents: (including padding for variables of recruitment, site activity, etc.)

Grand Total = 3750 respondents.

Number of Responses per Respondent: 15.

Estimated Time per Response:

Total Intercepts (one on one interviews) = 2810 × 30 min (per contractor) = 84,300/60 = 1405 hours.

Total Focus Groups = 1060 × 2 hrs (per contractor) = 2120 hours.

Total Estimated Hours of Burden not to exceed = 3525 hours.

Estimated Total Annual Burden on Respondents: Public reporting burden for this collection of information is estimated to average 3750 respondents with a total estimated burden of 3525 hours.

The Salmon-Challis NF embraces Integrated Pest Management (IPM) practices (as defined in Forest Service Handbook 3409) in managing various pests, including noxious and invasive non-native weeds. This philosophy is predicated on the principle that a single management method will not be successful; but that implementing a fully integrated approach in weed management significantly improves the chances of a successful program. A variety of activities can be carried out under an IPM program and provides for a full range of management strategies, including prevention and public education.

Weeds can alter ecosystem processes, including productivity, decomposition, hydrology, nutrient cycling, and natural disturbance patterns such as frequency and intensity of wildfires. Changing these processes can lead to displacement of native plant species, eventually impacting wildlife and native plant habitat, recreational opportunities, natural hydrologic processes, and scenic beauty. The economic effects from the subsequent loss of productivity and resource values can be considerable.

The Draft EIS will focus on restoring native species and wildlife habitat while reducing runoff and erosion by containing and reducing weed infestations and seed sources throughout the forest, controlling the spread of existing weeds, and preventing the establishment of new weed species. This project will encompass portions of the S-CNF, with complete analysis expected by January 2003.

Potential alternatives for weed management may include mechanical, biological, vegetative (e.g. seedings), controlled grazing, and ground-based and aerial herbicide applications. Methods of management will be evaluated based on environmental concerns, management restrictions, and site characteristics to ensure weed management activities are as successful as possible. The project area and analysis will encompass the entire Salmon-Challis National Forest excluding the Frank Church River of No Return Wilderness, an area of approximately 3,108,827 acres. Specific treatment areas may be throughout the project area and would include big game summer and winter range, roads, trails, trailheads, administrative sites, and other emphasis areas such as disturbed sites and high use areas. preliminary issues identified for analysis in the EIS include the potential effects and relationship of the project to human health risk, water quality, fisheries, native plant communities, wildlife habitat, soil productivity, recreation, scenery, heritage resources, and sensitive plants.

The Forest Service intends to schedule at least three public information meetings before the close of the comment period. For the Forest Service to best use the scoping input, comments should be received by January 31, 2002.

Public participation will be an integral component of the study process, and will be especially important at several points during the analysis. The first is during the scoping process. The Forest Service will be seeking information, comments, and assistance from Federal, State, County, and local agencies, individuals, and organizations that may be interested in or affected by the proposed activities. The scoping process will include: (1) Identification of potential issues, (2) identification of issues to be analyzed in depth, (3) identification of alternatives and (4) elimination of non-significant issues or those that have been covered by previous environmental reviews. Written scoping comments will be solicited through a scoping package that will be sent to the project mailing list and local newspapers.

At this early stage, the Forest Service believes it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of Draft EIS's must structure their participation in the environmental review of the proposal, so that it is meaningful and alerts an agency to the reviewer's position and contentions. Vermont Yankee Nuclear Power Corp. v NRDC, 435 U.S. 519, 553, (1978). Also, environmental objections that could have been raised at the Draft EIS stage, but that are not raised until completion of the Final EIS, may be waived or dismissed by the courts. City of Angoon v. Hodel, 803 F.2nd 1016, 1022 (9th Cir. 1986) and Wisconsin Heritages, Inc. v. Harris, 490 F. Supp. 1334, 1338 (E.D. Wis. 1980). Because of these court rulings, it is very important that those interested in this proposed action participate by the close of the 45-day comment period on the Draft EIS, so that substantive comments and any objections are made available to the Forest Service at a time when they can be meaningfully considered and responded to in the Final EIS.

To assist the Forest Service in identifying and considering issues and concerns of the proposed action, comments on the Draft EIS should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the Draft EIS. Comments may address the adequacy of the Draft EIS, as well as the merits of the alternatives formulated and discussed in the Draft EIS. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act in 40 CFR 1503.3, in addressing these points.

The South Tahoe Public Utility District's (District) owns and operates an effluent export system that pumps treated effluent from the District's wastewater treatment plant in South Lake Tahoe to the Harvey Place Reservoir in Alpine County, CA. The export system is divided into three segments, the A-Line, B-Line, and C-Line. The B-Line consists of the portion of the pipeline between the Luther Pass Pump Station and the top of Luther Pass where the force main breaks to gravity. The original force main was installed in 1969/70 and utilized steel pipe that was installed using poorly monitored construction techniques. Problems developed soon after the installation was completed, and have continued as the line has aged. Construction is currently being completed on the reach that extends from the 1980 replacement to the gravity break at Luther Pass (approximately 9,982 lineal feet known as B-Line Phase II). The current proposal will extend from the Luther Pass Pump Station to the middle of the Forest Service campground (where the Phase I replacement began) and will result in the complete replacement of the original B-Line pipeline. The proposal is to authorize the District to construct Phase III of the B-Line Export Pipeline. The project includes the construction of a new effluent export pipeline between the Luther Pass Pump Station and the project's terminus within the campground east of State Route 89. This segment of the B-Line pipeline is located approximately 3.5 miles south of Meyers, CA. The project would consist of a pressurized 24-inch-diameter pipeline placed below ground level. The pipeline trench would be a minimum of 7 feet deep and approximately four to six feet wide, depending upon soil conditions. The 24-inch diameter pipeline replaces an existing 20-inch diameter pipeline. Following replacement, the existing pipeline would be abandoned in place.

The pipeline would be constructed using excavators and rubber-tired loaders, with the steel pipe welded onsite. The welding and coating activity would take place adjacent to and above the trench. Following welding and pipeline coating activities, the pipe segments (up to 1,000 feet in length) would be placed into the trench. Due to the need to conduct welding along side the pipeline trench, all ground vegetation will need to be removed within the immediate trench corridor to avoid the risk of wild fire. The proposed widths for the construction corridor are provided below.

Within the campground road, an option exists to use a rock-trencher for trenching activities. The benefit of using a rock-trencher is that it requires a narrower construction corridor than traditional construction methods (vehicles can work front to back rather than side by side). However, the rock trencher is much heavier than an excavator or other rubber-tired equipment and requires a more stable base from which to operate.

A 50-foot-wide temporary construction easement has been requested by the District for the pipeline construction within forested areas. Within the 50-foot easement, a 25-foot-wide construction corridor will be established to allow construction of the trench. Within the 25-foot-wide construction corridor, trees, surface vegetation and top soil would either be removed or significantly disturbed by construction equipment. The trench does not need to be centered within this corridor, rather the corridor can be shifted to allow for significant trees and rock outcrops to be preserved. However, 25-feet is the minimum clearance area needed for construction of the pipeline. Adjacent to the 25-foot corridor, and within the 50-foot temporary easement, tree removal would only occur if approved beforehand by the Forest Service and TRPA. Within this portion of the easement, disturbance would occur from construction equipment access and material storage. Following construction, the 50-foot construction easement and any adjacent soil disturbance caused by construction activities will be revegetated pursuant to Forest Service and TRPA approved plans.

Pipeline Replacement Alternatives A and B (described below) would cross Highway 89 in one location. At the crossing locations, project construction activities would be timed to avoid the simultaneous closure of both travel lanes on Highway 89. Delays due to lane closure shall not exceed 30 minutes. Open trenches in Highway 89 would be backfilled or covered with non-skid plates during times when construction activities are stopped.

Pipeline Replacement Alternative C would follow Highway 89 from its intersection with Grass Lake Road to the intersection with the campground road. Within this corridor, 24-hour lane closures would be required seven days a week, including the use of “K” rail to separate construction activities from the open travel lane. Blasting would be required for trenching within the right-of-way. During blasting activities, traffic would be held in both directions.

To prevent erosion and discharge into down-slope drains or low lying drainages, pipeline trench erosion control practices shall be used. Erosion control practices would require filter fabric fencing down slope of construction activities. No erosion or runoff shall be allowed to reach any adjacent creeks. Under alternatives B and C, the pipeline will cross Grass Lake Creek. In these locations, more detailed erosion control and restoration plans will be required to ensure adequate diversion of the creek flows during pipeline construction. The pipeline will cross Grass Lake Creek in two of the three action alternatives (Alternatives B and C). One of the creek crossings would occur in an undisturbed area to the north of the South Upper Truckee Road (Alternative B). At this creek crossing location, the project would require the construction of a temporary roadway to facilitate equipment access. The creek will be temporarily diverted using pumps or placed in a culvert under the temporary roadway during construction. After construction is completed, the roadway material will be removed and the creek will be restored to pre-project conditions. Two other creek crossings would occur within Highway 89 for Alternative C and within the campground road for Alternatives B and C. In both locations, the creek flows through a culvert. The Highway 89 crossing would occur within the roadway prism and above the existing box culvert. The campground road crossing would also occur within the roadway prism, but could either be constructed underneath or above the existing corrugated metal pipe (cmp). Construction of the pipeline underneath the cmp would require removal and replacement of the culvert. Construction of the pipeline above the cmp would avoid effects to the cmp but would require raising the road grade.

It is anticipated that some groundwater will be intercepted during trenching activities. In order to prevent the discharge of trench waters, water collected from dewatering operations shall be disposed as follows: (1) Water from the pipeline trench will be pumped into a settling tank or water trucks with sufficient volume to handle projected water quantities, (2) water will be decanted from the settling tanks or trucks for use as construction water during backfilling operations, (3) settled water will be taken to the Luther Pass summit and placed in the gravity export pipeline (C-Line) that flows to the Harvey Place reservoir, or (4) settled water will be placed in the sanitary sewer in Grass Lake Road.

The South Upper Truckee Road is proposed for temporary material stockpiling and equipment staging. To use the roadway for material stockpiling and staging, the District will request its closure. This roadway is under the control of the El Dorado County Department of Transportation. The proposed closure would be located between Highway 89 and the roadway's crossing of the Upper Truckee River (west of Highway 89). Stockpile areas will be surrounded by filter fabric fencing, and covered with plastic sheeting prior to storm events. Historic trail resources adjacent to the roadway will be protected by temporary construction fencing.

To protect trees within the 50-foot construction easement (outside of the 25-foot construction corridor), vegetation protection fencing will be installed around every live tree or group of trees greater than 6 inches dbh. In addition, no tree roots greater than 1.5 inches in diameter shall be cut without the prior authorization of the Forest Service and TRPA. In situations where tree roots greater than 1.5 inches must be cut, the contractor shall treat the roots in accordance with standard practices. All areas disturbed by construction activity shall be revegetated. The revegetation shall be with a matching seed mix to restore the loss of vegetation that will result from pipeline construction. A goal of vegetation/site restoration following construction shall be to ensure that the pipeline corridor does not become a new trail for recreational bicyclists.

Groundwater channeling would be minimized by using an aggregate (Class 2) fill for the pipeline bedding zone (this zone is the area 6 inches under the pipeline to one foot above the pipeline). Any excavated soils that are wet require air drying to proper moisture content or mixing with drier soils prior to being used as compacted backfill. In addition, the installation of trench cutoff walls or “coffer dams” is proposed in areas where high groundwater and the slope of the terrain would dictate that groundwater channeling is a probability.

During pipeline trenching, field inspections of the trenches would be performed to make final determinations regarding the need for cutoff walls to control potential high groundwater flows. During construction, the pipeline will be pressure tested at 2,000 foot intervals. The pressure testing will be performed using potable water. At the conclusion of construction, the entire segment of new pipeline will be tested before it is placed into operation.

The construction of the pipeline must comply with TRPA's standard conditions of approval and the Handbook of Best Management Practices (BMPs) Standards. The use of BMPs will be documented in a Stormwater Pollution Prevention Plan (SWPPP) prepared for approval by CA. Regional Water Quality Ccontrol Board, Lahontan Region. The purpose of the SWPPP is to provide a site-specific plan for preventing storm water pollution caused by construction activities, including land disturbance. The SWPPP will be designed to comply with the federal requirements to achieve compliance with the effluent limits and receiving water objectives set forth in the California General NPDES Permit for Discharges of Storm Water Associated with Construction Activities through implementation of BMPs. The SWPPP will be implemented concurrent with the commencement of construction activities.

Alternatives: Four alternatives have been identified for further study in the STPUD B-Line Phase III Export Pipeline Replacement Project EIR/EIS. Alternative A—Parallel Existing Pipeline Alignment would parallel the existing pipeline alignment through National Forest lands from the Luther Pass Pump Station to the project's terminus in the Forest Service campground. However, the pipeline would not use the existing pipeline's trench because it would still be in operation during construction. The pipeline would parallel the existing pipeline with at least 50 feet of separation from the existing pipeline to avoid damage during construction activities, such as blasting. This alternative would be approximately 4,400 feet in length. Alternative B—Proposed Action would begin at the Luther Pass Pump Station and end within the Forest Service campground at a connection with the B-Line Phase I replacement project. The total length of the proposed action is approximately 5,900 feet. The proposed action would begin at the pump station, generally follow the hillside contours to the south, cross Grass Lake Creek, cross South Upper Truckee Road twice, continue on to Highway 89, cross Highway 89, follow the campground access road, and end at the terminus of the B-Line Phase I replacement project that was constructed in 1996. Alternative C—Parallel Existing Roadways would follow existing roadway rights-of-way. This alternative would use Grass Lake Road to the intersection of Highway 89. At the intersection of Grass Lake Road and Highway 89, the alternative would follow Highway 89 south to the campground access road. At this intersection, Alternative C would follow the same route as Alternative B to the project's terminus. This alternative would be approximately 16,000 feet in length. Approximately 8,700 feet of the pipeline alignment would be located within Highway 89. Of this total, approximately 60 percent (5,200 feet) would have to be located inside the fog line of the highway (within the roadway pavement). Due to the pipeline's length, additional storage capacity may be needed at the Luther Pass Pump Station to allow for the draining of the pipeline during maintenance operations. This additional storage capacity would require construction of a third storage tank, or enlargement of an existing tank. As a sub-alternative to Alternative C, the Luther Pass Pump Station may be relocated to a location near the intersection of Grass Lake Road and Highway 89. Alternative D—No Project/No Action would maintain the existing pipeline that was constructed in 1969. While no immediate action would occur, the continued use of the existing pipeline will increase the chances of a pipeline break. Pipeline breaks require immediate repair by the District.

Commenting: The draft environmental impact statement is expected to be available for public review and comment in May 2002. The comment period on the draft statement will be at least 45 days from the date of availability published in the Federal Register by the Environmental Protection Agency. The final environmental impact statement and its Record of Decision is expected in October 2002.

The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft EIS's must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions. Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 553 (1978). Also, environmental objections that could be raised at the draft EIS stage but that are not raised until after completion of the final EIS may be waived or dismissed by the courts. City of Angoon v. Hodel, 803 F.2d 1016, 1022 (9th Circut, 1986) and Wisconsin Heritages, Inc. v. Harris, 490 F. Supp. 1334, 1338 (E.D. Wis. 1980). Because of these court rulings, it is very important that those interested in this proposed action participate by the close of the comment period so that substantive comments and objections are made available to the Forest Service at a time when it can meaningfully consider them and respond to them in the final EIS. To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments should be as specific as possible. It is helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the draft EIS or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points. The decision will be appealable under applicable Forest Service regulations.

Agenda items to be covered include: (1) Introductions of all committee members, alternate members and Forest Service personnel. (2) Selection of a chairperson by the committee members. (3) Receive materials explaining the process for considering and recommending Title II projects; and (4) Public Comment. The meeting is open to the public. Public input opportunity will be provided and individuals will have the opportunity to address the Committee at that time.

Agenda items to be covered include: (1) Introductions of all committee members, alternate members and Forest Service personnel. (2) Selection of a chairperson by the committee members. (3) Receive materials explaining the process for considering and recommending Title II projects; and (4) Public Comment. The meeting is open to the public. Public input opportunity will be provided and individuals will have the opportunity to address the Committee at that time.

On July 13, August 3, August 10, August 17, October 19 and October 26, 2001, the Committee for Purchase From People Who Are Blind or Severely Disabled published notices (66 FR 36741, 40671, 42197, 43180, 53201, 54193/94) of proposed additions to and deletions from the Procurement List:

After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the commodities and services and impact of the additions on the current or most recent contractors, the Committee has determined that the commodities and services listed below are suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the commodities and services to the Government.

2. The action will not have a severe economic impact on current contractors for the commodities and services.

3. The action will result in authorizing small entities to furnish the commodities and services to the Government.

4. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the commodities and services proposed for addition to the Procurement List.

Accordingly, the following commodities and services are added to the Procurement List:

This action does not affect current contracts awarded prior to the effective date of this addition or options that may be exercised under those contracts.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action will not have a severe economic impact on future contractors for the commodities and services.

3. The action will result in authorizing small entities to furnish the commodities and services to the Government.

4. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the commodities and services deleted from the Procurement List.

After consideration of the relevant matter presented, the Committee has determined that the commodities listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.

Accordingly, the following commodities are deleted from the Procurement List:

This notice is published pursuant to 41 U.S.C. 47(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the possible impact of the proposed actions.

If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice for each commodity will be required to procure the commodities listed below from nonprofit agencies employing persons who are blind or have other severe disabilities. I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the commodities to the Government.

2. The action will result in authorizing small entities to furnish the commodities to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the commodities proposed for addition to the Procurement List. Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information. The following commodities are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

The Corporation is a federal government corporation that encourages Americans of all ages and backgrounds to engage in community-based service. This service addresses the nation's educational, public safety, environmental, and other human needs to achieve direct and demonstrable results. In addressing those needs, we strive to foster civic responsibility, strengthen the ties that bind us together as Americans, and provide educational opportunities for those who make a substantial commitment to service. We support a range of national service programs, including AmeriCorps, Learn and Serve America, and the National Senior Service Corps.

AmeriCorps*VISTA, a component of AmeriCorps, is authorized under the Domestic Volunteer Service Act of 1973, as amended (Pub. L. 93-113). The statutory mandate of AmeriCorps*VISTA is “to strengthen and supplement efforts to eliminate and alleviate poverty and poverty-related problems in the United States by encouraging and enabling persons from all walks of life, all geographical areas, and all age groups . . . (to) assist in the solution of poverty and poverty-related problems, and . . . to generate the commitment of private sector resources, to encourage volunteer service at the local level, and to strengthen local agencies and organizations to carry out the purpose (of the program).” (42 U.S.C. 4951) AmeriCorps*VISTA carries out its legislative mandate by assigning individuals 18 years and older, on a full-time, year-long basis, to public and private nonprofit organizations whose goals are in accord with AmeriCorps*VISTA's legislative mission. Each AmeriCorps*VISTA project must focus on the mobilization of community resources, the transference of skills to community residents, and the expansion of the capacity of community-based organizations to solve local problems. Programming should encourage permanent, long-term solutions to problems confronting low-income communities rather than short-term approaches for handling emergency needs.

AmeriCorps*VISTA project sponsors must actively elicit the support and/or participation of local public and private sector elements in order to enhance the chances of a project's success as well as to make the activities undertaken by AmeriCorps*VISTA members self-sustaining when the Corporation no longer provides resources.

The purpose of this announcement is to support the use of financial/business strategies to fight poverty by building financial assets for individuals, organizations, and communities. Financial asset development is an important strategy designed to move people out of poverty. It provides people with the financial security to escape poverty for the long term by purchasing a car or home, furthering their education, or starting a business. For community organizations, it can provide the means to achieve long-term stability by adopting recognized business practices, diversifying revenue streams, and applying technology.

Financial assets for individuals include individual development accounts (IDAs), home ownership, small business start-up, financial/entrepreneurial education, or other equity-building strategies. Increased equity offers financial stability for individuals moving out of poverty, provides opportunities for investment in education, diversifies income streams, and enables low-income individuals to escape poverty.

Likewise, many struggling nonprofit organizations can benefit from organizational financial asset development. Some examples of organizational financial asset development include diversifying income sources (including for-profit enterprises within nonprofit structures), purchasing real estate, and increasing efficiencies through the application of technology.

For many low-income communities with little economic development and few service providers, there are few opportunities to use new skills or to build asset values in property. With limited small business development and single, large employers, the community becomes over-dependent on one source of jobs and can be devastated by small changes in the economy or choices to move production elsewhere. Community asset development strategies to overcome these structural problems include developing credit unions, cooperatives, and small business opportunities for low-income entrepreneurs. Each of these institutions can enable low-income, asset-poor communities to become self-sufficient and not dependent on single financial, employment, or consumer institutions. The designation of enterprise zones is an excellent example of targeting resources to specific communities in order to build community assets.

State and/or local public agencies, and nonprofit private organizations that are local, statewide, regional, or national in scope are eligible to apply under this announcement. Organizational and community financial asset development efforts are frequently supported through social venture capital institutions that are committed to investment in antipoverty enterprises with a view toward long-term return. These types of philanthropic entities, if public or non-profit private organizations, are encouraged to apply.

Pursuant to the Lobbying Disclosure Act of 1995, an organization described in section 501(c)(4) of the Internal Revenue Code of 1986, 26 U.S.C. 501(c)(4), which engages in lobbying, is not eligible to apply.

AmeriCorps*VISTA projects traditionally work with local community-based organizations and it is anticipated that all projects under this announcement will have at least three (3) AmeriCorps*VISTA members. If a project is national in scope, it is anticipated that each project will support between 25 and 50 AmeriCorps*VISTA members on a full-time basis for one year of service and that each local project affiliated with the national project will support at least three (3) members.

Applicants are encouraged to request AmeriCorps*VISTA Leaders for projects of eight (8) or more members. Leaders are former AmeriCorps*VISTA members who have completed a year of service in the AmeriCorps*VISTA program or have completed two years of service with the Peace Corps. They are charged with coordinating member activities across the project and assisting in recruitment and training activities.

Some applicants may want to apply for the Summer Associate program as part of their application. Summer Associates serve for 8-10 weeks on a full-time basis to bring an additional infusion of energy and expertise to achieving the projects' goals. Summer Associates receive the same living allowance (pro-rated for their length of service) and a partial education award, but are not eligible for relocation funds or national training. For example, applicants may consider incorporating into the proposal the placement of MBA students or business major undergraduates as a Summer Associate component to their project. An organization cannot propose a Summer Associates program without also proposing a full-year AmeriCorps*VISTA project.

Quality supervision of AmeriCorps*VISTA projects are critical for their success. At a minimum, there should be one full-time supervisor dedicated exclusively to the project for every 20 AmeriCorps*VISTA members and the equivalent prorated level for projects with fewer members. Supervision grants, if requested, are restricted to supporting a portion of the salary package of a person employed to directly supervise AmeriCorps*VISTA projects and for travel by staff listed under Project Personnel in the budget. No supervision grant can be less than $20,000 and typically does not exceed $1,000 per AmeriCorps*VISTA member requested.

Project applicants, particularly those applying for supervision grants, should demonstrate their commitment to matching the federal contribution toward the operation of the AmeriCorps*VISTA project by offsetting all, or part of, the costs of member supervision, transportation, on-site orientation and training, as well as the basic costs of the program itself (e.g., space, telephone, etc.). This support can be achieved through cash or in-kind contributions, and it must be documented in the budget.

Further, applicant organizations are encouraged to share in costs traditionally covered by federal funds. In a cost-share arrangement, sponsoring organizations cover the living allowance (approximately $9,400 per member) for a specified number of AmeriCorps*VISTA positions. The Corporation will pay for training, relocation allowances, education awards, health care, and other expenses relating to the members' service.

Applications must demonstrate a multi-year development plan including work plans for individual members, broken down by quarter. Projects may be awarded for a three or five year project period and approved on a twelve-month cycle. The Corporation has no obligation to provide additional funding or AmeriCorps*VISTA placements for subsequent years. Continuation of a project, and possible funding of a supervisory grant, for approved projects is contingent upon the availability of funds, satisfactory progress in relation to the approved objectives, submission of proposed changes in activities or objectives, a detailed budget and budget narrative for the applicable program year, and other criteria established in the Memorandum of Agreement and grant award agreement. AmeriCorps*VISTA projects are usually expected to achieve capacity-building goals at a given site within three (3) years, or five (5) years if there is significant cost-share participation. Typically, these project time lines are broken down into quarterly benchmarks to ensure the achievement of work plan objectives. Applicants under this announcement should describe a clear time frame for the project to achieve new capacity, identify regular objectives and/or outcomes for intermediate achievements, and describe the proposed transition at the conclusion of the project time line. Satisfactory performance ratings during annual reviews will be based on meeting the time lines proposed in the application.

Publication of this announcement does not obligate the Corporation to award any specific number of grants, or to obligate the entire amount of funds or members available, or any part thereof, for grants under the AmeriCorps*VISTA program, or to approve any specific number of non-grant projects for the placement of AmeriCorps*VISTA members.

The Corporation will provide technical assistance to applicants under this announcement to complete project applications, including detailed budgets.

Applicant organizations must demonstrate: the existing capacity and experience needed to monitor and support a project; previously demonstrated strong institutional commitment of personnel, resources, training, and technical expertise; and a well-coordinated project rather than loosely tying together several unrelated activities.

The Corporation State Offices will work with those governmental agencies and organizations selected as project sites to finalize Part B (CNS Form 1421B) (OMB Control Number 3045-0038) of the project application, assist in recruiting and training members to serve as AmeriCorps*VISTA members, and discuss various implementation issues including in-service training and technical assistance for members. The Corporation State Office also provides training to AmeriCorps*VISTA supervisors. The sponsoring organization is required to submit a Project Progress Report (CNS Form 1433) (OMB Control Number 3045-0043) to the Corporation State Office on a federal fiscal year quarterly basis.

1. A one-page narrative summary description, single-spaced, single-sided, of the proposed AmeriCorps*VISTA project including the name, address, telephone number, and contact person for the applicant organization. The summary should include the expected long-term antipoverty outcomes of the project, a description of what will be created that did not exist before the project started, and a description of how the project will be sustained once AmeriCorps*VISTA resources are withdrawn. The summary will be used as a project abstract to provide reviewers with an introduction to the substantive parts of the application. Therefore, care should be taken to produce a summary that accurately and concisely reflects the proposal.

2. Application for Federal Assistance (SF 424) (OMB Approval Number 0348-0043), including the Part II Budget. This is a standard form used by applicants as a required face sheet for applications requesting federal assistance. It includes attachments requiring signatures to ensure that applicants comply with all other relevant federal laws, rules and regulations, and certifications that: (a) The applicant has not been debarred from receiving federal assistance, (b) that it has a drug-free work plan, and (c) that it will comply with federal requirements governing lobbying activities.

3. Part A (CNS Form 1421A) (OMB Control Number 3045-0039) containing a description of the organization's mission, population to be served, experience in the areas of service, and specific problems of poverty to be addressed. In addition, the applicant must state:

• The specific needs of the low-income community or communities that will be served by the project, particular challenges facing that community, the scarcity of similar programs providing financial asset development opportunities, and recent demographic or socioeconomic changes that have increased challenges to the low-income community or communities.

• The specific strategy that will be used to achieve the financial asset development goals and how the success of that strategy will be measured.

• The long-term impacts that the new strategy, once institutionalized, will have on helping people out of poverty.

• The elements necessary for that strategy to be sustainable after AmeriCorps*VISTA resources are withdrawn.

• The activities that members undertake in each of the three years to achieve institutionalization of the strategy.

• The applicant's experience in coordinating the efforts of community volunteers and/or service participants.

• The resources that exist to support the project, including the organizations that will serve as collaborators, the amount of cost-share investment the applicant can make, the additional resources dedicated to training members, and whether housing will be provided.

4. Part B (CNS Form 1421B) (OMB Control Number 3045-0038) which includes a measurable and quantifiable description of the specific problem(s) the AmeriCorps*VISTA project will address, current activities to address the problem, and how AmeriCorps*VISTA members will complement this effort. This section needs to address site specific information and include the following:

• A detailed work plan must be completed for the first year of the project; it should contain objectives that are measurable, quantifiable, and time-phased according to specific milestones established by the applicant. A more general work plan must be submitted for each of the subsequent years. While there is no standard project length, the AmeriCorps*VISTA resource is a time-limited form of assistance and the application should provide a timetable necessary to complete the project. An evolution of AmeriCorps*VISTA member work plans from the first year of the project to the last should clearly show how the project will reach maturity and then phase out in a way that leads to sustained support from the sponsor and its community partners.

• A list of the tasks and activities of the AmeriCorps*VISTA member assignments, required skills and qualifications of members, and factors to be considered in assigning members with disabilities.

• A description of the applicant's strategy for recruiting qualified AmeriCorps*VISTA members, including a sample position description for the online AmeriCorps recruitment system for each type of member desired.

• A description of how members will be supervised.

• A description of how project beneficiaries will be involved in the planning of the project (including its development and implementation), what resources will be provided by the community for a successful project, and how the community will be involved in assuring project sustainability.

• An overview of the content of an on-site orientation and training (typically one to three weeks) that the applicant will provide to enable members to quickly understand their assignment and the community in which they are serving.

• A description of on-going training and technical assistance the applicant will provide to their AmeriCorps*VISTA members.

• Plans for publicizing the project, recognizing member accomplishments, and generating community support in sustaining the project.

5. Documentation in the form of letters of support from collaborating organizations and/or individuals stating what will be provided by them in the overall project effort.

6. Copy of Articles of Incorporation (not applicable to public governmental entities).

7. List of Board of Directors or governing body (not applicable to public governmental entities).

8. Organizational chart illustrating the location of the AmeriCorps*VISTA project within the overall applicant organization.

9. List of Advisory Council Members if already selected.

10. Tax exempt status: either IRS determination or copy of application to IRS for exemption (not applicable to public governmental entities).

11. Copy of supervisor's resume and job description.

12. Copy of most recent financial audit if available.

13. A list of potential local project sponsors including all necessary contact information.

All of the following elements will be used in judging the applications:

The proposed project must:

1. Describe the community or communities that will be served and explain why they are of particular need at this time. The explanation may include comparable poverty rates, recent demographic changes, or data indicating a concerning shift, lack of financial asset development programs (for individual asset development projects) or nonprofit management services available (for organizational projects), etc.

2. Address the needs of low-income communities and otherwise comply with the provisions of the Domestic Volunteer Service Act of 1973, as amended (42 U.S.C. 4951 et seq. ) applicable to AmeriCorps*VISTA and all applicable published regulations, guidelines, and Corporation policies.

3. Contain clear and measurable objectives/outcomes in the project application during the proposed timeline for the project (with quarterly benchmarks) that address the overall objectives of the initiative. Applicants must show how the new capacity the AmeriCorps*VISTA members will build will contribute to specific outcomes related to increased opportunity for low-income people. It is expected that outcome objectives will reflect the evolution of the project.

4. Indicate how the proposed project complements and/or enhances activities already underway in the communities that will be served by the project. To the extent possible, applicant organizations should seek out opportunities to collaborate with other Corporation programs, as well as with other community partners, including universities and colleges, the business sector, and foundations.

5. Describe how the number of AmeriCorps*VISTA members requested is appropriate for the project goals/objectives, and how the skills requested are appropriate for the assignment(s).

The applicant organization must:

1. Describe how the financial asset development strategy described will help provide a clear step on the road to allowing people to leave poverty for the long-term.

2. Describe how the project will develop a new and sustainable capacity in the local community to effectively support the long-term financial asset strategies.

3. Demonstrate collaboration with organizations that provide supportive services to enhance project outcomes.

4. Explain how the project will be designed to generate public and/or private sector resources, and to promote local, part-time volunteer service at the community level.

5. Describe in measurable terms the anticipated outcomes at the conclusion of the project, including outcomes related to the sustainability of the project activities and the project's impact on poverty.

The applicant organization must:

1. Clearly state how AmeriCorps*VISTA members will be trained, supervised, and supported to ensure the achievement of project goals and objectives as stated in the project work plan.

2. Describe any additional benefits that will be provided members in order to make the assignment more attractive or offer value to the member when he or she has completed service. Additional consideration will be given to proposals that include partnering with universities and colleges for academic credit, collaboration with financial institutions and other businesses, and for housing the members. An AmeriCorps*VISTA member may take, at any given time, no more than one educational course that must be directly related to the member's project assignment and/or be part of a member's career plan. Advance permission of the project supervisor and the Corporation State Program Director is required to take these courses.

3. Describe how AmeriCorps*VISTA assignments are designed to use the full-time AmeriCorps*VISTA members' time to the maximum extent.

The applicant organization must:

1. Ensure that resources needed to achieve project goals and objectives are available.

2. Have the management and technical capability to implement the project successfully.

3. Have demonstrated experience in addressing the issues proposed by the project application.

4. Have systems for evaluating and monitoring project activities. Applicants must describe the methods that will be used to track progress toward the stated objectives, and the procedures that will provide the feedback needed to make adjustments that improve project quality.

5. Invest its own resources in the administration, management, and supervision of members.

6. Consider cost-sharing AmeriCorps*VISTA members and if they are unable to do so, including future plans for possibly supporting cost-shared slots.

7. Explore partnering with higher education institutions and the business community in order to support this antipoverty initiative.

The applicant organization must:

1. Include a budget that adequately supports the project design.

2. Include a budget that adheres to budget guidance provided with the application.

3. Describe how the applicant organization is committing resources necessary for project implementation.

To ensure fairness to all applicants, the Corporation reserves the right to take action, up to and including disqualification, in the event that an application fails to comply with any requirements specified in this Notice.

The following weights will be used in judging the elements described above.

1. Program Design (60%) in the following order of importance:

a. Responsiveness to Strengthening Communities Criteria (25%)

b. Responsiveness to Getting Things Done Criteria (15%)

c. Responsiveness to Member Development Criteria (10%)

2. Organizational Capacity including demonstrated capacity in addressing proposed issues (25%).

3. Budget/Cost-Effectiveness (15%).

After evaluating the overall quality of the proposal and its responsiveness to the criteria noted above, the Corporation will take into consideration whether funded projects are in areas of high concentration of low-income residents, including for example those in empowerment zones and enterprise communities, and rural champion communities.

Corporation authority to make these grants and approve projects is authorized under Title I, Part A of the Domestic Volunteer Service Act of 1973, as amended (Pub. L. 93-113).

The Department of the Army systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on November 29, 2001, to the House Committee on Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, ‘Federal Agency Responsibilities for Maintaining Records About Individuals,’ dated February 8, 1996 (February 20, 1996, 61 FR 6427).

The Defense Logistics Agency notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on December 5, 2001, to the House Committee on Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, ‘Federal Agency Responsibilities for Maintaining Records About Individuals,’ dated February 8, 1996 (February 20, 1996, 61 FR 6427).

EPA ICR No. 1885.01; IAQ Practices in Schools Survey; in 40 CFR part 68 was approved 07/27/01; OMB No. 2060-0463; expires 07/31/2004.

EPA ICR No. 2004.01; 2001 Emergency Planning and Community Right-to-know Act (EPCRA) and Risk Management Program (RMP) Implementation Status Questionnaire for Tribal Emergency Response Commission in 40 CFR part 68; was approved 08/13/2001; OMB No. 2009-0001; expires 08/31/2004.

EPA ICR No. 1755.05; Regulatory Reinvention Pilot Projects Under Projects XL: Pretreatment Program; was approved 08/01/2001; OMB No. 2010-0026; expires 02/28/2002.

EPA ICR No. 1425.05; Application for Reimbursement to Local Governments for Emergency Response to Hazardous Substance Releases Under CERCLA section 123 in 40 CFR part 310; was approved 08/21/2001; OMB No. 2050-0077; expires 08/31/2004.

EPA ICR No. 0155.07; Certification of Pesticide Applicators in 40 CFR part 171 was approved 08/24/2001; OMB No. 2070-0029; expires 08/31/2004.

EPA ICR No. 1715.03; TSCA Section 402 and Section 404 Training and Certification, Accreditation and Standards for Lead-Based Paint Activities in 40 CFR part 745 was approved 08/24/2001; OMB No. 2070-0155; expires 08/31/2004.

EPA ICR No. 1928.02; Information Collection Request for Filter Backwash Recycling Rule (Final Rule) in 40 CFR 141.76 and 142.16; OMB No. 2040-0224; was approved 08/14/2001; expires 08/31/2004.

EPA ICR No. 1988.01; 2001 Aquatic Animal Production Industry Surveys; was approved 08/01/2001; OMB No. 2040-0237; expires 08/31/2004.

EPA ICR No. 0866.06; Quality Assurance Specification and Requirements; was approved 08/29/2001; OMB No. 2080-0033; expires 08/31/2004.

EPA ICR No. 1446.07; PCB's Consolidated Reporting and Recordkeeping Requirements; in 40 CFR part 61; was approved on 08/29/2001; OMB No. 2070-0112; expires 08/31/2004.

EPA ICR No. 0922.06; Data Call-Ins for the Special Review and Registration Review Programs; was approved 08/29/2001; OMB No. 2070-0057; expires 08/31/2004.

EPA ICR No. 1695.07; Certification and the Averaging, Banking, and Trading Program for Non-road Spark-Ignition Engines at or Below 19 Kilowatts, in 40 CFR part 90, subpart C; was approved 09/21/2001; OMB No. 2060-0338; expires 09/30/2004.

EPA ICR No. 1862.02; Transition Program for Equipment Manufacturers, in 40 CFR part 89.101; was approved 09/21/2001; OMB No. 2060-0369; expires 09/30/2004.

EPA ICR No. 1718.03; Tax-exempt (Dyed) Highway Diesel Fuel; Requirements for Transferors and Transferees; in 40 CFR part 80.29(c), was approved 09/21/2001; OMB No. 2060-0308; expires 09/30/2004.

EPA ICR No. 0193.07; NESHAP for Beryllium in 40 CFR part 61, subpart C; was approved 09/21/2001; OMB No. 2060-0092; expires 09/30/2004.

EPA ICR No. 1722.03; Spark-ignition Marine Engine Application for Emission Certification and Participation in the Averaging, Banking and Trading Program in 40 CFR part 91, subpart B and C; was approved 09/21/2001; OMB No. 2060-0321; expires 09/30/2004.

EPA ICR No. 1681.04; NESHAP: Epoxy Resin and Non-Nylon Polyamide Production in 40 CFR part 63, subpart W; was approved 09/21/2001; OMB No. 2060-0290; expires 09/30/2004.

EPA ICR No. 1725.03; Marine Engine Manufacturer Production Line Testing Reporting and Recordkeeping Requirements, in 40 CFR part 91; was approved 09/21/2001; OMB No. 2060-0323; expires 09/30/2004.

EPA ICR No. 1761.03; Regulations for a Voluntary Emissions Standards Program Applicable to Manufacturers of Light-Duty Vehicles and Trucks Beginning in Model Year 1997 in part 40 CFR 86.1700; was approved 09/21/2001; OMB No. 2060-0345; expires 09/30/2004.

EPA ICR No. 1684.05; Non-Road Compression-Ignition Engine and On-Highway Heavy Duty Engine Application for Emissions Certification, and Participation in the Averaging, Banking, and Trading Program in 40 CFR 86.094, was approved 09/25/2001; OMB No. 2060-0287; expires 09/30/2004.

EPA ICR No. 1767.03; MACT for Primary Aluminum Reduction Plants in 40 CFR part 63, subpart LL; was approved 09/25/2001; OMB No. 2060-0360; expires 09/30/2004.

EPA ICR No. 1504.04; Data Generation for Pesticide Reregistration; in 40 CFR part 158 was approved 09/07/2001; OMB No. 2070-0107; expires 09/30/2004.

EPA ICR No. 1922.02; Storage, Treatment, Transportation, and Disposal of Mixed Waste (Final Rule); in 40 CFR part 266 was approved 08/02/2001; OMB No. 2050-0181; expires 08/31/2004.

EPA ICR No. 1976.01; National Emission Standards for Hazardous Air Pollutants (NESHAP) for Reinforced Plastic Composites Production; in 40 CFR part 63, subpart WWWW on 09/21/2001 OMB filed a comment under comment No. 2060-0466. Note, this is not an OMB approval number.

EPA ICR No. 1637.04; General Conformity of Federal Actions to State Implementation Plans, 40 CFR part 51, subpart W and 40 CFR part 93, subpart B; OMB No. 2060-0279; on 9/28/2001 OMB extended the expiration date through 12/30/2001.

EPA ICR No. 1976.01; National Emission Standards for Hazardous Air Pollutants (NESHAP) for Reinforced Plastic Composites Production; in 40 CFR part 63, subpart WWWW on 09/21/2001 OMB filed a comment under comment No. 2060-0466. Note, this is not an OMB approval number.

EPA ICR No. 1954.01; National Emission Standards for Hazardous Air Pollutant; Surface Coating of Large Appliances; in 40 CFR part 63, subpart NNNN on 09/21/2001 OMB filed a comment under comment No. 2060-0457. Note, this is not an OMB approval number.

You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number PF-1061. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1061 in the subject line on the first page of your response.

1. By mail . Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier . Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

3. Electronically . You may submit your comments electronically by e-mail to: opp-docket@epa.gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number PF-1061. Electronic comments may also be filed online at many Federal Depository Libraries.

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT .

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Make sure to submit your comments by the deadline in this notice.

7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the petitioner and represents the view of the petitioner. EPA is publishing the petition summary verbatim without editing it in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

EPA has received a pesticide petition (PP EUP-LN) from Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of spinosad in or on the raw agricultural commodity stored grain (wheat, barley, corn, oats, rice, and sorghum/milo) at 3 parts per million (ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

1. Plant metabolism . The metabolism of spinosad in plants (apples, cabbage, cotton, tomato, and turnip) and animals (goats and poultry), are adequately understood for the purposes of these tolerances. A rotational crop study showed no carryover of measurable spinosad-related residues in representative test crops.

2. Analytical method . There is a practical method (immunoassay) for detecting (0.005 ppm) and measuring (0.01 ppm) levels of spinosad in or on food with a limit of detection that allows monitoring of food with residues at or above the level set for these tolerances. The method has had a successful method tryout in EPA's laboratories.

3. Magnitude of residues . Tolerances as high as 10 ppm (Brassica) and 8 ppm (leafy vegetables) have been previously established for crop commodities treated with spinosad. Magnitude of residue studies were conducted at three sites for artichokes. Residues found in these studies ranged from 0.062 ppm to 0.156 ppm. Magnitude of residue studies were conducted at three sites for asparagus. Residues found in these studies were all less than 0.009 ppm. Magnitude of residues studies were conducted at five sites for garden beet tops (one of the representative crops for the leaves of root and tuber vegetable crop group). Residues found in these studies ranged from 0.03 ppm to 4.0 ppm. Previously submitted data used in support of the established residue tolerance on Brassica (cole) leafy vegetables are also to be used in support of the proposed residue tolerance for leaves of root and tuber vegetables. Magnitude of residue studies were conducted at six sites for pears (one of the representative crops for the pome fruit crop group). Residues found in these studies ranged from non-detectable to 0.08 ppm. Previously submitted data used in support of the established residue tolerance on apples are to be used in support of the proposed residue tolerance for pome fruit. Magnitude of residue studies were conducted at four sites on pecans (one of the representative crops for the tree nut crop group). Residues found in these studies ranged from less than 0.0010 ppm to 0.0076 ppm. Previously submitted data used in support of the established residue tolerance on almonds are also to be used in support of the proposed residue tolerance for tree nuts and pistachio. A magnitude of residue study was conducted at 20 sites on tomatoes and peppers (two of the representative crops for the fruiting vegetables crop group). Residues found in this study ranged from less than 0.01 ppm to 0.13 ppm in tomatoes, and 0.01 ppm to 0.18 ppm in peppers. Previously submitted data used in support of the established residue tolerance on fruiting vegetables (except cucurbits) are to be used in support of the proposed residue tolerance for okra. Magnitude of residue studies were conducted at six sites for cranberry. No quantifiable residues ( > 0.01 ppm) were observed in any test sample. Magnitude of residue studies were conducted at five sites for garden beet roots (one of the representative crops for the root and tuber vegetable crop group) and tops (one of the representative crops for the leaves of root and tuber vegetable crop group). Residues found in beet tops ranged from 0.03 ppm to 4.0 ppm. Previously submitted data used in support of the established residue tolerance on Brassica (cole) leafy vegetables are also to be used in support of the proposed residue tolerance for leaves of root and tuber vegetables. This data support tolerances of 0.1 ppm in garden and sugar beet roots and a 10.0 ppm tolerance for Crop Group 2.

1. Acute toxicity . Spinosad has low acute toxicity. The rat oral LD 50 is 3,738 milligrams/kilograms (mg/kg) for males and > 5,000 mg/kg for females, whereas the mouse oral LD 50 is > 5,000 mg/kg. The rabbit dermal LD 50 is > 5,000 mg/kg and the rat inhalation LC 50 is > 5.18 miligram/liter (mg/L) air. In addition, spinosad is not a skin sensitizer in guinea pigs and does not produce significant dermal or ocular irritation in rabbits. End use formulations of spinosad that are water based suspension concentrates have similar low acute toxicity profiles.

2. Genotoxicity . Short-term assays for genotoxicity consisting of a bacterial reverse mutation assay (Ames test), an in vitro assay for cytogenetic damage using the chinese hamster ovary (CHO) cells, an in vitro mammalian gene mutation assay using mouse lymphoma cells, an in vitro assay for DNA damage and repair in rat hepatocytes, and an in vivo cytogenetic assay in the mouse bone marrow (micronucleus test) have been conducted with spinosad. These studies show a lack of genotoxicity.

3. Reproductive and developmental toxicity . Spinosad caused decreased body weights in maternal rats given 200 mg/kg/day by gavage (highest dose tested (HDT)). This was not accompanied by either embryo toxicity, fetal toxicity, or teratogenicity. The no observed adverse effect levels (NOAELs) for maternal and fetal toxicity in rats were 50 and 200 mg/kg/day, respectively. A teratology study in rabbits showed that spinosad caused decreased body weight gain and a few abortions in maternal rabbits given 50 mg/kg/day highest dose tested (HDT). Maternal toxicity was not accompanied by either embryo toxicity, fetal toxicity, or teratogenicity. The NOAELs for maternal and fetal toxicity in rabbits were 10 and 50 mg/kg/day, respectively. In a 2-generation reproduction study in rats, parental toxicity was observed in both males and females given 100 mg/kg/day highest dose tested (HDT). Perinatal effects (decreased litter size and pup weight) at 100 mg/kg/day were attributed to maternal toxicity. The NOAEL for maternal and pup effects was 10 mg/kg/day.

4. Subchronic toxicity. Spinosad was evaluated in 13-week dietary studies and showed NOAELs of 4.89 and 5.38 mg/kg/day, respectively in male and female dogs; 6 and 8 mg/kg/day, respectively in male and female mice; and 33.9 and 38.8 mg/kg/day, respectively, in male and female rats. No dermal irritation or systemic toxicity occurred in a 21-day repeated dose dermal toxicity study in rabbits given 1,000 mg/kg/day.

5. Chronic toxicity . Based on chronic testing with spinosad in the dog and the rat, EPA has set a reference dose (RfD) of 0.027 mg/kg/day for spinosad. The RfD has incorporated a 100-fold safety factor to the NOAELs found in the chronic dog study to account for interspecies and intraspecies variation. The NOAELs shown in the dog chronic study were 2.68 and 2.72 mg/kg/day, respectively for male and female dogs. The NOAELs (systemic) shown in the rat chronic/carcinogenicity/neurotoxicity study were 9.5 and 12.0 mg/kg/day, respectively for male and female rats. Using the Guidelines for Carcinogen Risk Assessment published in the Federal Register September 24, 1986 (51 FR 33992), it is proposed that spinosad be classified as Group E for carcinogenicity (no evidence of carcinogenicity) based on the results of carcinogenicity studies in two species. There was no evidence of carcinogenicity in an 18-month mouse feeding study and a 24-month rat feeding study at all dosages tested. The NOAELs shown in the mouse oncogenicity study were 11.4 and 13.8 mg/kg/day, respectively for male and female mice. A maximum tolerated dose was achieved at the top dosage level tested in both of these studies based on excessive mortality. Thus, the doses tested are adequate for identifying a cancer risk. Accordingly, a cancer risk assessment is not needed.

Spinosad did not cause neurotoxicity in rats in acute, subchronic, or chronic toxicity studies.

6. Animal metabolism . There were no major differences in the bioavailability, routes or rates of excretion, or metabolism of spinosyn A and spinosyn D following oral administration in rats. Urine and fecal excretions were almost completed in 48-hours post-dosing. In addition, the routes and rates of excretion were not affected by repeated administration.

7. Metabolite toxicology . The residue of concern for tolerance setting purposes is the parent material (spinosyn A and spinosyn D). Thus, there is no need to address metabolite toxicity.

8. Endocrine disruption . There is no evidence to suggest that spinosad has an effect on any endocrine system.

1. Dietary exposure . For purposes of assessing the potential dietary exposure from use of spinosad on the raw agricultural commodities listed in this notice, as well as from other existing spinosad crop uses, a conservative estimate of aggregate exposure is determined by basing the theoretical maximum residue contribution (TMRC) on the proposed tolerance level for spinosad and assuming that 100% of the proposed new crops and other existing (registered for use) crops grown in the U.S. were treated with spinosad. The TMRC is obtained by multiplying the tolerance residue levels by the consumption data which estimates the amount of crops and related foodstuffs consumed by various population subgroups. The use of a tolerance level and 100% of crop treated clearly results in an overestimate of human exposure and a safety determination for the use of spinosad on crops cited in this summary that is based on a conservative exposure assessment. In addition, for the use of dermal application of spinosad to cattle, the risk assessment applies a conservative (overestimate) 35% of market share for the dermal application to cattle, to the tolerance levels for animal commodities based on existing crop uses.

Drinking water . Another potential source of dietary exposure is residues in drinking water. Based on the available environmental studies conducted with spinosad wherein its properties show little or no mobility in soil, there is no anticipated exposure to residues of spinosad in drinking water. In addition, there is no established maximum concentration level (MCL) for residues of spinosad in drinking water.

2. Non-dietary exposure . Spinosad is currently registered for use on a number of crops including cotton, fruits, and vegetables in the agriculture environment. Spinosad is also currently registered for outdoor use on turf and ornamentals at low rates of application (0.04 to 0.54 lb active ingredient per acre) and indoor use for drywood termite control (extremely low application rates used with no occupant exposure expected). Thus, the potential for non-dietary exposure to the general population is considered negligible.

The potential for cumulative effects of spinosad and other substances that have a common mechanism of toxicity is also considered. In terms of insect control, spinosad causes excitation of the insect nervous system, leading to involuntary muscle contractions, prostration with tremors, and finally paralysis. These effects are consistent with the activation of nicotinic acetylcholine receptors by a mechanism that is clearly novel and unique among known insecticidal compounds. Spinosad also has effects on the gamma aminobatopic acid (GABA) receptor function that may contribute further to its insecticidal activity. Based on results found in tests with various mammalian species, spinosad appears to have a mechanism of toxicity like that of many amphiphilic cationic compounds. There is no reliable information to indicate that toxic effects produced by spinosad would be cumulative with those of any other pesticide chemical. Thus, it is appropriate to consider only the potential risks of spinosad in an aggregate exposure assessment. Spinosad is classified in a mechanism-of-action group of its own for the purpose of resistance management in insects and for rotation with other crop protection products.

1. U.S. population . Using the conservative exposure assumptions and the RfD described above, the aggregate exposure to spinosad use on existing crop uses utilizes 36.9% of the RfD for the U.S. population from a previous EPA assessment based on the chronic population adjusted dose (cPAD) (as posted in the Federal Register of May 3, 2000 (65 FR 25721) (FRL-6555-9)). EPA generally has no concern for exposures below 100% of the RfD, because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. The new crop uses proposed in this notice are minor ones and are expected to contribute only a negligible impact to the RfD. Thus, it is clear that there is reasonable certainty that no harm will result from aggregate exposure to spinosad residues on existing and all pending crop uses listed in this notice.

2. Infants and children . In assessing the potential for additional sensitivity of infants and children to residues of spinosad, data from developmental toxicity studies in rats and rabbits and a 2-generation reproduction study in the rat is considered. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from pesticide exposure during prenatal development. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability and potential systemic toxicity of mating animals and on various parameters associated with the well-being of pups.

FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base. Based on the current toxicological data requirements, the data base for spinosad relative to prenatal and postnatal effects for children is complete. Further, for spinosad, the NOAELs in the dog chronic feeding study which was used to calculate the RfD (0.027 mg/kg/day) are already lower than the NOAELs from the developmental studies in rats and rabbits by a factor of more than 10-fold. Concerning the reproduction study in rats, the pup effects shown at the HDT were attributed to maternal toxicity. Therefore, it is concluded that an additional uncertainty factor (UF) is not needed and that the RfD at 0.027 mg/kg/day is appropriate for assessing risk to infants and children. In addition, EPA has determined that the 10X factor to account for enhanced sensitivity of infants and children is not needed because:

i. The data provided no indication of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to spinosad. In the prenatal developmental toxicity studies in rats and rabbits and 2-generation reproduction in rats, effects in the offspring were observed only at or below treatment levels that resulted in evidence of parental toxicity.

ii. No neurotoxic signs have been observed in any of the standard required studies conducted.

iii. The toxicology data base is complete and there are no data gaps.

iv. Exposure data are complete or is estimated based on data that reasonably account for potential exposure.

Using the conservative exposure assumptions previously described (tolerance level residues), the percent RfD utilized by the aggregate exposure to residues of spinosad on existing crop uses is 81.9% for children 1 to 6 years old, the most sensitive population subgroup from an EPA assessment based on the cPAD (as posted in the Federal Register of May 3, 2000). Additional refinements to the dietary exposure based on market share information would reduce the exposure of children 1 to 6 years old to less than 50% the cPAD. Grain treated under a temporary tolerance is expected to contribute only a negligible impact to the RfD. Thus, based on the completeness and reliability of the toxicity data and the conservative exposure assessment, it is concluded that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to spinosad residues on the above proposed uses, including existing crop uses.

There is no Codex maximum residue levels established for residues of spinosad.

You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number PF-1060. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1060 in the subject line on the first page of your response.

1. By mail . Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

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Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT .

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EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

The petitioner's summaries of pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of petitions were prepared by the petitioner and represents the view of the petitioner. EPA is publishing the petitions summaries verbatim without editing them in any way. The petitions summaries announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such methods are needed.

EPA has received pesticide petitions (0E6167, 1E6347 and 1F6235) from the Interregional Research Project Number 4 (IR-4), 681 US Highway #1 South, North Brunswick, NJ 08902 and Uniroyal Chemical Company Inc., Middlebury, CT 06749 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR 180.377 by establishing tolerances for residues of diflubenzuron, ( N -(4-chlorophenyl)amino]carbonyl-2,6-difluorobenzamide) in or on the following raw agricultural commodities:

• PP 0E6167 proposes the establishment of a tolerance for pear at 0.5 part per million (ppm).

• PP 1E6347 proposes the establishment of a tolerance for the grass, forage, fodder, and hay group at 6.0 ppm.

• PP 1F6235 proposes the establishment of tolerances for stonefruit (except cherries) at 0.05 ppm, tree nuts and pistachios at 0.05 ppm, almond hulls at 5.0 ppm, peppers at 1.0 ppm, and meat-by-products at 0.15 ppm.

EPA has determined that the petitions contain data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on the petitions. This notice of filing contains a summary of the petition provided by Uniroyal Chemical Company, Inc., the registrant.

1. Plant metabolism . The nature of the residue in plants is adequately understood. The metabolism of diflubenzuron was investigated in soybeans, oranges, and rice. The main component of residues in rice was p-chlorophenylurea (CPU); levels of p-chloroaniline (PCA) were negligible to non-detectable. The main component of the residues in soybeans and oranges was the parent diflubenzuron (DFB). A considerable portion of the residues were bound. DFB showed very limited absorption and translocation in plants with most of the residues remaining on the surface.

2. Analytical method . Practical analytical methods for detecting levels of DFB, CPU and PCA, in or on food with a limit of detection that allows monitoring of the residue at or above the level set in the tolerance was used to determine residues in the proposed commodities. Residues of the individual analytes are detectable and quantifiable using three separate analytical methods. Residues of DFB are extracted from the proposed commodities with dichloromethane. Extracts are purified with deactivated florisil. An aliquot of the extract is hydrolyzed with phosphoric acid and the DFB is partitioned into hexane. The resulting extract is derivatized in heptafluorobutyric anhydride (HFBA). Quantification of DFB is accompanied by gas chromatography using an electron capture detector.

The analytical method for quantitation of the 4-chlorophenylurea requires ethyl acetate extraction of the residue from the matrix. Column chromatography is utilized for clean-up of the extract immediately prior to derivitization with HFBA. Derivatized extracts are analyzed by gas chromatography equipped with an electron capture detector.

The analysis for the determination of PCA residues from the proposed commodities utilize an internal standard method. Samples of matrix to be analyzed are fortified with the internal standard. Residues of 12C-PCA and the internal standard are subjected to acid and base hydrolysis. The final extract is passed through florisil column for clean-up and derivatized with HFBA in hexane. An aliquot of the derivatized extract is analyzed by gas chromatography using a mass spectrometry detector in the selective ion monitoring mode. Recovery of PCA is determined by the combined peak areas for the two mass spectral ions obtained from the derivatized 12C-PCA relative to the response factor derived from the combined areas of the corresponding two mass spectral ions from the internal standard.

3. Magnitude of residues . Individual residue trials have been conducted with diflubenzuron on the proposed commodities. Analyses of these trials show that the maximum total residue for diflubenzuron and its conversion products PCA and CPU will be at or below the proposed tolerance levels.

1. Acute toxicity . Studies for diflubenzuron technical indicate the acute oral toxicity in rats and mice is > 4,640 milligram per kilogram (mg/kg), and the acute dermal toxicity in rats is > 10,000 mg/kg. The acute inhalation lethal concentration (LC) 50 in rats is > 35 mg/L (6 hours). Diflubenzuron technical is not an eye or skin irritant to rabbits, and is not a dermal sensitizer in guinea pigs.

2. Genotoxicity . Diflubenzuron did not show any mutagenic activity in point mutation assays employing S. typhimurium , S. cerevisiae , or L5178Y Mouse Lymphoma cells. Diflubenzuron did not induce chromosomal aberrations in chinese hamster ovary (CHO) cells and it did not induce unscheduled DNA synthesis (UDS) in human WI-38 cells. Diflubenzuron was also negative in mouse micronucleus and mouse dominant lethal assays and it did not induce cell transformation in Balb/3T3 cells.

3. Developmental and reproductive . In a rat developmental toxicity study, diflubenzuron was administered by oral gavage to pregnant female rats at dosage levels of 0, 1, 2, and 4 mg/kg/day. No treatment-related effects were seen. A subsequent study was conducted in pregnant Sprague Dawley rats at a dose of 0 and 1,000 mg/kg/day. No maternal toxicity was observed. The incidence of fetuses with skeletal abnormalities was slightly increased in the treated group, but was within historical background range. The no observed adverse effect level (NOAEL) for maternal and developmental toxicity in rats was greater than 1,000 mg/kg/day.

Diflubenzuron was also administered by oral gavage to pregnant New Zealand white rabbits at dosage levels of 0, 1, 2, and 4 mg/kg/day. No treatment-related effects were seen. A subsequent study was conducted in pregnant rabbits at a dose of 0 and 1,000 mg/kg/day. No maternal or developmental toxicity was seen. The NOAEL for maternal and developmental toxicity in rabbits was greater than 1,000 mg/kg/day.

In a rat reproduction study, diflubenzuron was fed to 2-generations of male and female rats at dietary concentrations of 0, 10, 20, 40, and 160 ppm. No effects were seen on parental body weight gain and there were no reproductive effects. A subsequent study was conducted on one generation (1 litter) of rats at dietary concentrations of 0, 1,000, and 100,000 ppm. Systemic effects were seen in adults at these doses but there was no effect on reproductive parameters. The NOAEL for reproductive toxicity was greater than 100,000 ppm (5 g/kg/day).

4. Subchronic toxicity. To assess subchronic toxicity, a 4-week inhalation study and a 3-week dermal study were conducted. In the inhalation study rats were exposed nose only to 10, 30, or 100 milligram per cubic meters (mg/m 3 ) for 6 hours per day, 5 days per week for 4 weeks. Treatment-related findings were a slight reduction in erythrocytes, hemoglobin and hematocrit in male and female rats at a concentration of 100 mg/m 3 and an increase in total bilirubin in high dose female rats. There was no effect on methemoglobin concentration at any dose level. The NOAEL for subchronic inhalation toxicity was 30 mg/m 3 .

To assess subacute dermal toxicity, diflubenzuron was applied to the backs of male and female CD rats for 3 weeks at dose levels of 20, 500, and 1,000 mg/kg/day. Hematology evaluation showed reductions in red blood cell (RBC), hemoglobin (Hgb) and hematocrit values at 500 and 1,000 mg/kg/day. An increased incidence of polychromasia, hypochromasia, and anisocytosis was seen at 500 and 1,000 mg/kg/day. An increase in methemoglobin and sulfhemoglobin values was seen at 1,000 mg/kg/day. The NOAEL for systemic toxicity was 20 mg/kg/day. Also, a dermal absorption factor of 0.5%, for systemic absorption, was derived from a study where rats were dosed with either 0.005 or 0.05 mg/cm 2 of ( 14 C) diflubenzuron technical. This value can be used for converting dermal exposure to oral equivalents.

5. Chronic toxicity . Diflubenzuron was given by capsule to male and female Beagle dogs for 1 year at dose levels of 0, 2, 10, 50, and 250 mg/kg/day. Body weight (bwt) gain was slightly reduced in females at 250 mg/kg/day. Absolute liver and spleen weights were increased in males given 50 and 250 mg/kg/day. A reduction in hemoglobin and mean corpuscular hemoglobin concentration, with an elevation in reticulocyte count, was seen at 50 and 250 mg/kg/day. Methemoglobin and sulfhemoglobin values were increased at doses of 10 mg/kg/day and greater. Histopathological findings were limited to pigmented macrophages and Kupffer cells in the liver at doses of 50 and 250 mg/kg/day. The NOAEL for chronic toxicity in dogs was 2 mg/kg/day.

Diflubenzuron was fed to male and female Sprague Dawley rats for 2 years at dose levels of 0, 156, 625, 2,500, and 10,000 ppm. Methemoglobin values were elevated in female rats at all dose levels and in male rats at the two highest dose levels. Sulfhemoglobin was elevated in females, only, at dose levels of 2,500 and 10,000 ppm. Mean corpuscular volume (MCV) and reticulocyte counts were increased in high dose females. Spleen and liver weights were elevated at the two highest doses. Histopathological examination demonstrated an increase in hemosiderosis of the liver and spleen, bone marrow and erythroid hyperplasia and areas of cellular alteration in the liver. In another study diflubenzuron was administered to male and female CD rats for 2 years at dose levels of 0, 10, 20, 40, and 160 ppm. Elevated methemoglobin levels were seen in high dose males and females. No additional effects, including carcinogenic findings, were observed. The NOAEL for chronic toxicity in rats was 40 ppm (2 mg/kg/day).

A 91-week carcinogenicity study in CFLP mice was conducted at doses of 0, 16, 80, 400, 2,000, and 10,000 ppm. There was no increase in tumor incidence as a result of diflubenzuron administration. Target organ effects included: Increased methemoglobin and sulfhemoglobin values, Heinz bodies, increased liver and spleen weight, hepatocyte enlargement, and vacuolation, extramedullary hemopoiesis in the liver and spleen, siderocytosis in the spleen and pigmented Kupffer cells. A NOAEL for these effects was 16 ppm (2 mg/kg/day).

Diflubenzuron was fed to male and female Sprague Dawley rats for 2 years at dose levels of 0, 156, 625, 2,500, and 10,000 ppm. Methemoglobin values were elevated in female rats at all dose levels and in male rats at the two highest dose levels. Blood sulfhemoglobin was elevated in females, only, at dose levels of 2,500, and 10,000 ppm. MCV and reticulocyte counts were increased in high dose females. Spleen and liver weights were elevated at the two highest doses. Histopathological examination demonstrated an increase in hemosiderosis of the liver and spleen, bone marrow and erythroid hyperplasia, and areas of cellular alteration in the liver. There was no increase in tumor formation. In another study, diflubenzuron was administered to male and female CD rats for 2 years at dose levels of 0, 10, 20, 40, and 160 ppm. Elevated methemoglobin levels were seen in high dose males and females. No additional effects, including carcinogenic findings, were observed.

6. Animal metabolism . DFB in rats at a single dose of 100 mg/kg and 5 mg/kg single and multiple oral doses depicted limited absorption from the gastrointestinal tract. No major difference was observed between the single and multiple doses. In single dose treatments, after 7 days, 20% and 3% of the applied dose 5 and 100 mg/kg, respectively, were excreted in urine, while 79% and 98% of the applied dose 5 and 100 mg/kg, respectively, were eliminated in the feces. Very little bioaccumulation in the tissues was observed. In the feces, only unchanged parent compound was detected. Several metabolites were observed in the urine which are, among others, 2,6-diflurobenzoic acid (DFBA), 2,6-difluorophippuric acid, 2,6-difluorobenzamide (DFBAM), and 2-hydroxydiflubenzuron (2-HDFB). An unresolved peak that was characterized as p-chloroaniline (PCA) and/or p-chlorophenylurea (CPU) was found. This latter peak accounted for about 2% of the administered dose (5 mg/kg). To resolve if PCA and CPU are indeed metabolites of DFB, rats were administered a single oral dose, 100 mg/kg of 14C DFB. The major metabolites identified in rat urine were 4-chloroaniline-2-sulfate, accounting for almost 50% of the total radioactive residue (TRR) in the urine and N -(4-chlorophenyl)oxamic acid which accounted for about 15% of the (TRR). Neither CPU, PCA nor their N -hydroxyl derivatives were found in rat urine at a limit of detection of 23 parts per billion (ppb). As in the previous study, DFB was the only residue found in the feces.

7. Metabolite toxicology . NCI/NTP conducted chronic feeding and gavage studies with p-chloroaniline (PCA), a minor potential metabolite of diflubenzuron, in Fischer 344 rats and B6C3F1 mice.

PCA was administered in the diet to Fischer 344 rats at dietary concentrations of 250 and 500 ppm for 78 weeks, followed by a 24-week observation period. A slight body weight depression was seen in high dose females rats, compared to controls. Survival was reduced in high dose males compared to controls. In male rats there was a slight increase in uncommon fibromas or fibrosarcomas of the spleen, which was not statistically significant. Non-neoplastic proliferative and chronic inflammatory lesions were found in spleens of treated rats. It was concluded that, under the conditions of the assay, sufficient evidence was not found to establish the carcinogenicity of PCA for Fischer 344 rats.

PCA was administered 5 days/week by oral gavage, as a hydrochloride salt in water, to male and female F344/N rats at doses of 0, 2, 6, or 18 mg/kg/day. Mean body weights of dosed rats were generally within 5% of those of controls throughout the study. High dose animals generally showed mild hemolytic anemia and dose-related methemoglobinemia. Non-neoplastic lesions seen were bone marrow hyperplasia, hepatic hemosiderosis, and splenic fibrosis, suggesting treatment-related effects on the hematopoietic system. Adrenal medullary hyperplasia was observed in high dose female rats. The incidence of uncommon sarcomas of the spleen was significantly increased in high dose male rats. A marginal increase in pheochromocytomas of the adrenal gland was seen in high dose male and female rats. It was concluded that, under the conditions of this 2-year gavage study, there was clear evidence of carcinogenic activity of PCA hydrochloride for male F344/N rats and equivocal evidence of carcinogenic activity of PCA hydrochloride for female F344/N rats.

PCA was administered in the diet to B6C3F6 mice at dietary concentrations of 2,500 and 5,000 ppm for 78 weeks followed by a 13-week observation period. A body weight depression was seen in treated mice of both sexes, compared to controls. An increased incidence of hemangiomas and hemangiosarcomas in spleen, kidney, liver, and other sites was seen in treated mice of both sexes; however this increase was not statistically significant compared to controls. Non-neoplastic proliferative and chronic inflammatory lesions were found in spleens of treated mice. The evidence was considered insufficient to conclusively relate the hemangiomatous tumors in mice to compound administration. It was concluded that, under the conditions of the assay, sufficient evidence was not found to establish the carcinogenicity of PCA for B6C3F1 mice.

PCA hydrochloride was administered 5 days/week by oral gavage to male and female B6C3F1 mice at doses of 0, 3, 10, or 30 mg/kg/day. Mean body weights of high dose male and female mice were generally within 5% of those of controls throughout the study. The incidence of hepatocellular adenomas or carcinomas (combined) was increased in a non-dose-dependent manner in treated male mice. Metastasis of carcinoma to the lung was seen in the high dose group. An increased incidence of hemangiosarcomas of the liver or spleen was seen in high dose male mice. It was concluded that, under the conditions of this 2-year gavage study, there was some evidence of carcinogenic activity of PCA hydrochloride for male B6C3F1 mice and no evidence of carcinogenic activity of PCA hydrochloride for female B6C3F1 mice.

In addition to PCA, 4-chlorophenylurea (CPU) is also a potential minor metabolite of diflubenzuron. By association with PCA, EPA has concluded that CPU has carcinogenic potential and the same carcinogenic potency (q 1 *) as PCA. In the NTP report of the PCA bioassay, it is proposed that PCA undergoes N -hydroxylation to form the corresponding N -hydroxylamine metabolites; N -hydroxylation of aromatic amines is a well know mechanism of aromatic amine carcinogenicity. This metabolite, or proximate carcinogen, is then conjugated to form the ultimate carcinogen capable of ionizing and reacting with DNA to form adducts which result in splenic tumor formation. An alternate mechanism involving toxicity resulting in erythrocyte damage, splenic scavenging, hemorrhage, hyperplasia and fibrosis and ultimately splenic tumor formation is also proposed, but both mechanisms are based on the formation of N -hydroxy PCA.

This metabolite also causes methemoglobinemia in animals. Therefore, methemoglobin formation can be used as an indicator of the presence of PCA and N -hydroxy metabolite. However, in recent CPU rat toxicity studies, both dietary (7-day) and gavage, and a CPU rat metabolism study, it has been demonstrated that CPU does not induce methemoglobin formation and it is neither metabolized to PCA nor forms an N -hydroxylamine derivative. Since N -hydroxylation is the required first step in the mechanism of action of PCA's carcinogenicity, it can be concluded that CPU's mechanism of action and toxicity is different from that of PCA's.

8. Endocrine disruption . The standard battery of required studies has been completed and evaluated to determine potential estrogenic or endocrine effects of diflubenzuron. These studies include an evaluation of the potential effects on reproduction and development, and an evaluation of the pathology of the endocrine organs following repeated or long-term exposure. These studies are generally considered to be sufficient to detect any endocrine effects. No such effects were noted in any of the studies with diflubenzuron.

1. Dietary exposure . Since 1-day single dose oral studies in rats and mice indicated only marginal effects, an acute exposure risk assessment is not needed, as there were no significant acute effects observed.

i. Food —a. Diflubenzuron . The chronic dietary exposure from diflubenzuron was estimated based on the average residue values from the various currently labeled raw agricultural commodities (RACs) and the proposed pear use. Percent of crop treated was also factored into the estimate. Residues in meat, milk, and egg products were obtained from extrapolation of metabolism study data to anticipated livestock dietary burdens. The dietary exposure analysis was estimated based on 1989-1992 USDA food consumption data.

For the U.S. population (total), the dietary exposure of diflubenzuron was estimated as 0.000027 mg/kg/day. For nursing and non-nursing infants, the exposure was estimated as and 0.000110 and 0.000304 mg/kg/day, respectively. For children, the exposure was 0.000046 and 0.000033 mg/kg/day for 1-6 year olds and 7-12 year olds, respectively.

b. p-Chloroaniline . The chronic dietary exposure from p-chloroaniline (PCA) which has been detected in some food products was also determined. Average residues from field trials for mushrooms, rice, pears, nut crops, and pistachios, stonefruit (except cherries), and peppers were used. Residues in liver were obtained from extrapolation of metabolism data to anticipated livestock dietary burdens. EPA has previously used a 2% in vivo conversion factor of DFB to PCA for foods derived from plant products. However, based on results of a recent rat metabolism study showing that no PCA is formed, this is no longer appropriate. The percent treated of each crop was also factored into the exposure estimate.

For the U.S. population (total), the dietary exposure of PCA was estimated as < 0.000001 mg/kg/day. For nursing and non-nursing infants, the exposure was estimated as 0.000002 and 0.000007 mg/kg/day, respectively. For children 1 to 6 years old and 7 to 12 years old, the exposure was 0.000001 mg/kg/day.

ii. Drinking water . Diflubenzuron degrades in soil relatively quickly with an aerobic half-life ranging from 3 to 7 days. Major degradates include difluorobenzoic acid (DFBA) and CPU. DFBA is further metabolized through decarboxylation and ring cleavage by soil microbes whereas CPU is slowly degraded to soil-bound entities. Under anaerobic aquatic conditions, diflubenzuron has a half-life of 34 days with the main degradates being DFBA and CPU. In surface water, diflubenzuron is degraded by microbes with a half-life of 5 to 10 days. The soil mobility of diflubenzuron is considered quite limited based on a number of experimental studies as well as by computer modeling. CPU has also been shown to be relatively immobile in soil. Although DFBA shows mobility in soil, it is rapidly degraded. Therefore, based on results of laboratory and field studies, it is not likely that diflubenzuron or its degradates will impact ground water quality to any significant extent.

Based on EPA's PRZM/EXAMS modeling, the average annual mean concentration of diflubenzuron in surface water sources is not expected to exceed 0.05 ppb. These values were determined using the maximum concentrations for any diflubenzuron crop uses including the proposed commodities. The drinking water level of concern (DWLOC) for chronic (non-cancer) exposure to diflubenzuron in drinking water was determined as 700 ppb for the U.S. population (total) and approximately 200 ppb for infants and children. The estimated maximum concentration of diflubenzuron in surface and ground water (0.05 ppb) is much less than the DWLOCs as a contribution to chronic (non-cancer) aggregate exposure.

2. Non-dietary exposure . Diflubenzuron is a restricted use pesticide based on its toxicity to aquatic invertebrates. This restricted use classification makes it unavailable for use by homeowners. Occupational uses of diflubenzuron may expose people in residential locations, parks, or forests treated with diflubenzuron. However, diflubenzuron has very low residues detected in forestry dissipation studies, low dermal absorption rate (0.05%), and extremely low dermal and inhalation toxicity.

Uniroyal Chemical Co. has considered the potential for cumulative effects of diflubenzuron and other substances with a common mechanism of toxicity. The mammalian toxicity of diflubenzuron is well defined. We are not aware of any other pesticide product registered in the United States that could be metabolized to p-chloroaniline. For this reason, consideration of potential cumulative effects of residues from pesticidal substances with a common mechanism of action as diflubenzuron is not appropriate. Thus only the potential exposures to diflubenzuron were considered in the total exposure assessment.

1. U.S. population . Based on the available toxicology and exposure data base for diflubenzuron, Uniroyal has determined that the total possible non-occupational aggregate exposure from diflubenzuron would occur from the dietary route. Dietary exposure to the U.S. population (total) from diflubenzuron was estimated at 0.000027 mg/kg/day. Based on the 0.02 mg/kg/day RfD (reference dose) derived from the dog chronic NOAEL of 2 mg/kg/day and a 100-fold safety factor, this dietary exposure is 0.1% of the RfD. Despite the potential for exposure to diflubenzuron in drinking water, aggregate exposure is not expected to exceed 100% of the RfD.

For PCA, Uniroyal has also determined that the total possible non-occupational aggregate exposure would occur from the dietary route. Dietary exposure to the U.S. population (total) from PCA was estimated as less than 0.000001 mg/kg/day. The risk from diflubenzuron-derived PCA can be estimated using a linear extrapolation of the dose-response from the rat chronic study conducted by the National Toxicology Program in which rats were dosed via gavage with p-chloroaniline (hydrochloride) for 24 months. EPA has determined the q 1 * as 0.0638 based on the combined sarcoma incidence in the spleen of male rats.

In view of the results of recent CPU rat mechanistic and metabolism studies, and the DFB rat metabolism study, the dietary risk assessment included here considers only actual residues of PCA found in food and animal by-products. This is consistent with a parent compound, such as diflubenzuron, which is negative (category E) for carcinogenicity.

Using the q 1 * of 0.0638, the risk to the U.S. population (total) from dietary exposure to diflubenzuron-derived PCA is 3.09 x 10 -8 .

2. Infants and children . The same assumptions as for the U.S. population were used for the dietary exposure risk determination in infants and children. The dietary exposure of diflubenzuron was calculated as 0.000110 and 0.000304 mg/kg/day, respectively for nursing and non-nursing infants. These values are 0.6% and 1.5%, respectively of the RfD for diflubenzuron. The dietary exposure from diflubenzuron in children 1 to 6 years and 7 to 12 years old was determined as 0.000046 mg/kg/day and 0.000033 mg/kg/day, respectively. These values are 0.2% of the RfD.

As previously discussed, the NOAELs for maternal and developmental toxicity in rats and rabbits were greater than 1,000 mg/kg/day, and the NOAEL for reproductive toxicity was greater than 5,000 mg/kg/day. Therefore, based on the completeness and reliability of the toxicity data and the conservative exposure assessment, Uniroyal concludes that there is reasonable certainty that no harm will result in infants and children from aggregate exposure to residues of diflubenzuron and its conversion products containing the p-chloroaniline moiety.

There is a Codex maximum residue limit (MRL) for pears at 1.0 mg/kg, a Mexican MRL at 1.0 mg/kg, and no limits set for Canada for pears. A Codex MRL has also been established for plums (including prunes) at 1.0 mg/kg. There are no Codex maximum residue limits established for other stonefruit, tree nuts or peppers.

You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

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You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1057 in the subject line on the first page of your response.

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EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The summary of the petition was prepared by the petitioner and represents the view of the petitioners. EPA is publishing the petition summary verbatim without editing it in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

EPA has received a pesticide petition (1E6349) from Sygenta Crop Protection Inc., P.O. Box 18300, Greensboro, NC 27419-8300 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of thiamethoxam and its metabolite, (N-(2-chloro-thiazol-5-ylmethyl)-N'methyl-N-nitro-guanidine, in or on the raw agricultural commodity imported green and roasted coffee beans and instant coffee at 0.05 parts per million (ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

1. Plant metabolism. The primary metabolic pathways of thiamethoxam in plants (corn, rice, pears, and cucumbers) were similar to those described for animals, with certain extensions of the pathway in plants. Parent compound, thiamethoxam, and its metabolite, (N-(2-chloro-thiazol-5-ylmethyl)-N'methyl-N-nitro-guanidine, were the major residues in all crops. The metabolism of thiamethoxam in plants and animals is understood for the purposes of the proposed tolerances. Parent thiamethoxam and the metabolite, are the residues of concern for tolerance setting purposes.

2. Analytical method. Syngenta Crop Protection Inc. has submitted practical analytical methodology for detecting and measuring levels of thiamethoxam in or on raw agricultural commodities. The method is based on crop specific cleanup procedures and determination by liquid chromatography with either ultraviolet (UV) or mass spectrometry (MS) detection. The limit of detection (LOD) for each analyte of this method is 1.25 nanogram (ng) injected for samples analyzed by UV and 0.25 ng injected for samples analyzed by MS, and the limit of quantitation (LOQ) is 0.005 ppm for milk and juices and 0.01 ppm for all other substrates.

3. Magnitude of residues. A residue program was performed for thiamethoxam on coffee as prescribed in draft EPA Guidance on Import Tolerances. A total of nine trials were conducted in the major coffee producing countries of Brazil (four), Columbia (three) and Mexico (two). The applications in these trials consisted of soil applications (trench, furrow or broadcast) at the proposed maximum rate of 300 grams active ingredient per hectare. The first applications were made just after petal fall and a second application at the beginning of fruit development. There were no detectable residues < 0.02 ppm of thiamethoxam or the metabolite CGA-322701 in coffee berries or dried green coffee beans.

In addition, there was a single 5X exaggerated rate processing trial conducted. There were detectable residues of thiamethoxam and its metabolite ( < 0.022 ppm and 0.012 ppm, respectively) in the dry beans for processing. There were no detectable residues ( < 0.005 ppm) of thiamethoxam or it metabolite, in roasted beans, ground roasted beans, brewed extracts, spent grounds or instant coffee.

1. Acute toxicity. The acute oral LD 50 for thiamethoxam in the rat is 1,563 mg/kg body weight. The acute dermal LD 50 of thiamethoxam is > 2,000 milligrams/kilogram (mg/kg) body weight. Thiamethoxam is non-toxic at atmospheric concentrations of 3.72 mg/L. Thiamethoxam is minimally irritating to the eye, non-irritating to skin, and is not a dermal sensitizer.

In an acute neurotoxicity screening study in rats (OPPTS 870.6200a), the no observed adverse effect level (NOAEL) was 100 mg/kg/day with a NOAEL of 500 mg/kg/day based on drooped palpebral closure, decrease in rectal temperature and locomotor activity and increase in forelimb grip strength (males only). At higher dose levels, mortality, abnormal body tone, ptosis, impaired respiration, tremors, longer latency to first step in the open field, crouched over posture, gait impairment, hypo-arousal, decreased number of rears, uncoordinated landing during the righting reflex test, slight lacrimation (females only), and higher mean average input stimulus value in the auditory startle response test (males only).

2. Genotoxicity. In gene mutation studies with S. typhimurium and E. coli (OPPTS 870.5100 and 870.5265), there was no evidence of gene mutation when tested up to 5,000 μg/plate and there was no evidence of cytotoxicity. In a gene mutation study with chinese hamster V79 cells at HGPRT focus (OPPTS 870.5300) there was no evidence of gene mutation when tested up to the solubility limit.

In a CHO cell cytogenetics study (OPPTS 870.5375) there was no evidence of chromosomal aberrations when tested up to cytotoxic or solubility limit concentrations.

An in vivo mouse bone marrow micronucleus study (OPPTS 870.5395) was negative when tested up to levels of toxicity in whole animals; however, there was no evidence of target cell cytotoxicity.

An UDS assay (OPPTS 870.5550) was negative when tested up to precipitating concentrations.

3. Reproductive and developmental toxicity. A prenatal developmental study in the rat (OPPTS 870.3700) resulted in maternal and developmental NOAELs of 30 mg/kg/day and 200 mg/kg/day, respectively. The maternal lowest observed adverse effect level (LOAEL) is 200 mg/kg/day based on decreased body weight, body weight gain and food consumption. The developmental LOAEL was 750 mg/kg/day based on decreased fetal body weight and an increased incidence of skeletal anomalies.

A prenatal developmental study in the rabbit (OPPTS 870.3700) resulted in maternal and developmental NOAELs of 50 mg/kg/day. The maternal and developmental LOAEL is 150 mg/kg/day. The maternal LOAEL is based on maternal deaths, hemorrhagic discharge, decreased body weight, and food intake during the dosing period. The developmental LOAEL is based on decreased fetal body weights, increased incidence of post-implantation loss and a slight increase in the incidence of a few skeletal anomolies/variations.

In a reproduction and fertility effects study in rats (OPPTS 870.3800) the parental/systemic NOAEL is 1.84 (males), 202.06 (females) mg/kg/day; the reproductive NOAEL is 0.61 (males), 202.06 (females) mg/kg/day, and the offspring NOAEL is 61.25 (males), 79.20 (females) mg/kg/day. The parental/systemic LOAEL is 61.25 (males), not determined (females) mg/kg/day based on increased incidence of hyaline change in renal tubules in F0 and F1 males. The reproductive LOAEL is 1.84 (males), not determined females mg/kg/day based on increased incidence and severity of tubular atrophy observed in testes of the F1 generation males. The offspring LOAEL is 158.32 (males), 202.06 (females) mg/kg/day based on reduced body weight gain during the lactation period in all litters.

4. Subchronic toxicity. A 90-day oral toxicity study in rats (OPPTS 870.3100) resulted in a NOAEL of 1.74 (males) and 92.5 (females) mg/kg/day. The LOAEL is 17.64 (male), 182.1 (female) mg/kg/day based on increased incidence of hyaline change of renal tubules epithelium (males), fatty change in adrenal gland of females, liver changes in females, all at the LOAEL.

A 90-day oral toxicity study in mice (OPPTS 870.3100) resulted in an NOAEL of 1.41 (males) and 19.2 (females) mg/kg/day. The LOAEL was 14.3 (male) and 231 (female) mg/kg/day based on an increased incidence of hepatocellular hypertrophy. At higher dose levels: decrease in body weight and body weight gain, necrosis of individual hepatocytes, pigmentation of Kupffer cells, and a lymphocytic infiltration of the liver in both sexes; slight hematologic effects and decreased absolute and relative kidney weights in males; and ovarian atrophy, decreased ovary and spleen weights and increased liver weights in females.

In a 90-day oral toxicity study in dogs (OPPTS 870.3150), the NOAEL is 8.23 (males) and 9.27 (females) mg/kg/day. The LOAEL is 32.0 (male), 33.9 (female) mg/kg/day based on slightly prolonged prothrombin times and decreased plasma albumin and A/G ration (both sexes); decreased calcium levels and ovary weights and delayed maturation in the ovaries (female); decreased cholesterol and phospholipid levels, testes weights, spermatogenesis, and spermatic giant cells in testes (male).

In a 28-day dermal study in rats (OPPTS 870.3200) the NOAEL was 250 (male) and 60 (female) mg/kg/day. The LOAEL was 1,000 (male),and 250 (female) mg/kg/day based on an increased plasma glucose, triglyceride levels, and alkaline phosphatase activity and an inflammatory cell infiltration in the liver and necrosis if single hepatocytes in females and a hyaline change in renal tubules and a very slight reduction in body weight in males. At higher dose levels in females, chronic tubular lesions in the kidneys and an inflammatory cell infiltration in the adrenal cortex were observed.

In a subchronic neurotoxicity screening study in rats (OPPTS 870.6200) the NOAEL was 95.4 (male) and 216.4 (female) mg/kg/day, both at the highest dose tested. The LOAEL was not determined. No treatment-related observations at any dose level. LOAEL was not achieved. May not have been tested at sufficiently high dose levels; however, a new study is not required because the weight of the evidence from other toxicity studies indicates no evidence of concern.

5. Chronic toxicity. In a chronic toxicity study in dogs (OPPTS 870.4100) the NOAEL was 4.05 (male), and 4.49 (female) mg/kg/day. The LOAEL was 21.0 (male) and 24.6 (female) mg/kg/day based on an increase of creatinine in both sexes, transient decrease in food consumption in females, and an occasional increase in urea levels, decrease in ALT, and atrophy of seminiferous tubules in males.

In a mouse carcinogenicity study (OPPTS 870.4200) the NOAEL was 2.63 (male) and 3.68 (female) mg/kg/day. The LOAEL was 63.8 (male) and 87.6 (female) mg/kg/day based on hepatocyte hypertrophy, single cell necrosis, inflammatory cell infiltration, pigment deposition, foci of cellular alteration, hyperplasia of Kupffer cells and increased mitotic activity, also an increase in the incidence of hepatocellular adenoma (both sexes). At higher doses, there was an increase in the incidence of hepatocelluar adenocarcinoma (both sexes) and the number of animals with multiple tumors, evidence of carcinogenicity. In a combined chronic caricinogenicity study in rats (OPPTS 870.4300), the NOAEL was 21.0 (male) and 50.3 (female) mg/kg/day. The LOAEL was 63.0 (male) and 255 (female) mg/kg/day based on an increased incidence of lymphocytic infiltration of the renal pelvis and chronic nephropathy in males and decreased body weight gain, slight increase in the severity of hemosiderosis of the spleen, foci of cellular alteration in liver and chronic tubular lesions in kidney in females. No evidence of carcinogenicity.

In a hepatic cell proliferation study in mice, the NOAEL was 16 (male) and 20 (female) mg/kg/day. The LOAEL was 72 (male) and 87 (female) mg/kg/day based on proliferative activity of hepatocytes. At higher dose levels, increases in absolute and relative liver weights, speckled liver, heptocellular glycogenesis/fatty change, heptocellular necrosis, apoptosis and pigmentation were observed.

In a 28-day feeding study to assess replicative DNA syntehsis in the male rat, the NOAEL was 711 mg/kg/day. The LOAEL was not established. Immunohistochemical staining of liver sections from control, and high dose animals for proliferating cell nuclear antigen gave no indication for a treatment-related increase in the fraction of DNA syntesizing hepatocytes in S-phase. Thiamethoxam did not stimulate hepatocyte cell proliferation in male rats.

In a special study to assess liver biochemistry in the mouse, the NOAEL was 17 (male) and 92 (female) mg/kg/day. The LOAEL was 74 (male) and 92 (female) mg/kg/day based on marginal to slight increases in absolute and relative liver weights, a slight increase in the microsomal protein content of the livers, moderate increases in the cytochrome P450 content, slight to moderate increases in the activity of several microsomal enzymes, slight to moderate induction of cytosolic glutathionw S-transfersase activity. Treatment did not affect peroxisomal fatty acid B-oxidation.

6. Animal metabolism. The metabolism of thiamethoxam in rats and livestock animals is adequately understood. The residues of concern have been determined to be parent thiamethoxam and its metabolite (N-(2-chloro-thiazol-5-ylmethyl)-N'methyl-N-nitro-guanidine).

7. Metabolite toxicology. For risk assessment purposes, residues of the metabolite corrected for molecular weight are considered to be toxicologically equivalent to parent thiamethoxam.

1. Dietary exposure. Permanent tolerances have been established (40 CFR 180.565) for the combined residues of the insecticide thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxadiazin-4-imine and it metabolite (N-(2-chloro-thiazol-5-ylmethyl)-N'-methyl-N-nitro-guanidine), in or on a variety of raw agricultutal commodities at levels ranging from 0.02 ppm to 1.5 ppm including barley, canola, cotton, sorghum, wheat, cucurbit vegetables, fruiting vegetables, pome fruits and livestock commodities. Pending tolerances include coffee, grapes, raisins, grape juice, pecans, peanut nutmeats, peanut hay, corn grain, sweet corn (kernal with husk removed), pop corn, corn forage and stover, head and stem brassica, leafy brassica greens and leafy vegetables.

i. Food —a. Acute risk . The acute dietary risk from food use tolerances previously set as published in the Federal Register of December 21, 2000 (65 FR 80343) (FRL-6758-1) and May 23, 2001 (66 FR 28386) (FRL-6784-7) indicate that acute dietary exposure from food will occupy 3% of the acute population adjusted dose (aPAD) for the U.S. population, 2% of the aPAD for females 13-50 years old, 8% of the aPAD for infants less than 1 year old and 7% of the aPAD for children 6-11 years old. Therefore, it is expected that the proposed tolerances for coffee will have minimal impact on acute dietary risk, and that the aggregate exposure will not exceed 100% of the aPAD.

b. Chronic risk . The chronic dietary risk from food use tolerances previously set as published in the Federal Register of December 21, 2000 (65 FR 80343), and May 23, 2001 (66 FR 28386) indicate that chronic dietary exposure from food will utilize 5% of the chronic population adjusted dose (cPAD) for the U.S. population, 13% of the cPAD for children 1-6 years old. Therefore, it is expected that the proposed tolerances for coffee will have minimal impact on chronic dietary risk and the aggregate exposure will not exceed 100% of the cPAD.

c. Cancer risk . Since there were no detectable residues of thiamethoxam or its metabolite in samples from the residue trials conducted in Brazil, Columbia and Mexico, it can be concluded that there is no increased cancer risk from the proposed use on imported coffee. Syngenta DEEM analysis indicates that the proposed tolerance on coffee contributes only 3.00 x 10 E-9 lifetime dietary cancer risk.

ii. Drinking water. Since the proposed tolerance is for imported coffee, there is no potential exposure from drinking water.

2. Non-dietary exposure. Thiamethoxam is not currently registered for use on any sites that would result in residential exposure.

The potential for cumulative effects of thiamethoxam, and other substances that have a common mechanism of toxicity has also been considered. Thiamethoxam belongs to a new pesticide chemical class known as the neonicotinoids. There is no reliable information to indicate that toxic effects produced by thiamethoxam would be cumulative with those of any other chemical including another pesticide. Therefore, Syngenta believes it is appropriate to consider only the potential risks of thiamethoxam in an aggregate risk assessment.

1. U.S. population. Syngenta concludes, as described above, that there is reasonable certainty that no harm to the U.S. population will result from aggregate acute or chronic dietary exposure to thiamethoxam residues including the proposed tolerances for imported coffee.

2. Infants and children. Syngenta concludes, as described above, that there is reasonable certainty that no harm to infants and children will result from aggregate acute or chronic exposure to thiamethoxam residues, including the proposed tolerances for imported coffee.

There are no Codex maximum residue levels established for residues of thiamethoxam on coffee.

OMB Control Number: 3060-0567.

Title: Section 76.962 Implementation and certification of compliance.

Form Number: N/A.

Type of Review: Delegated.

Respondents: Business or other for-profit entities, State, local or Tribal Government.

Number of Respondents: 500.

Estimated Time Per Response: .5 hours (30 minutes).

Total Annual Burden to Respondents: 250.

Total Annual Costs: $0.00.

Needs and Uses: Section 76.962 requires any cable operator that has been deemed subject to remedial requirements to certify to the Commission its compliance with the Commission order requiring prospective rate reductions, refunds or other relief to subscribers. The certification must be filed with the Commission within 90 days from the date the Commission released the order mandating a remedy. These certifications are used by the Commission to monitor a cable operator's compliance with Commission rate orders.

OMB Control Number: 3060-0668.

Title: Section 76.936 Written Decisions.

Form Number: N/A.

Type of Review: Delegated.

Respondents: State or Local, or Tribal government.

Number of Respondents: 1,200.

Estimated Time Per Response: 1 hour.

Total Annual Burden to Respondents: 1,200 hours.

Total Annual Costs: $0.

Needs and Uses: Section 76.936 states that a franchising authority must issue a written decision in a rate-making proceeding whenever it disapproves an initial rate for the basic service tier or associated equipment in whole or in part, disapproves a request for a rate increase in whole or in part, or approves a request for an increase whole or in part over the objection of interested parties. Franchising authorities are required to issue a written decision in rate-making proceedings pursuant to section 76.936 so that cable operators and the public are made aware of the proceeding.

OMB Control Number: 3060-0673.

Title: Section 76.956 Cable Operator Response.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 50.

Estimated Time Per Response: 4 hours.

Total Annual Burden to Respondents: 200 hours.

Total Annual Costs: $0.

Needs and Uses: Section 76.956 states that unless otherwise directed by the local franchising authority, a cable operator must file with the local franchising authority a response to a cable service complaint. In addition to responding to the merits of a complaint, the cable operator also may move for dismissal of the complaint for failure to meet the minimum showing requirement. The local franchising authority and the Commission use this information to ensure a process for cable operators to file a motion to dismiss a rate complaint filed against them if they feel that the complaint fails to meet the minimum showing.

OMB Control Number: 3060-0289.

Title: Section 76.76.601(a) Performance Tests, Section 76.1704(a)(b) Proof of Performance Test Data, Section 76.1705 Performance Tests (Channels Delivered).

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 10,838.

Estimated Time Per Response: .5-70 hours.

Total Annual Burden to Respondents: 328,379 hours.

Total Annual Costs: $3,000.00.

Needs and Uses: These rules require that the operator of each cable television system shall be responsible for insuring that each such system is designed, installed, and operated in a manner that fully complies with the provisions of the Commission rules. In addition, the rules require proof of performance tests and identify files to be maintained and a list of channels that a system delivers to its subscribers. The Commission uses this information to assure compliance with such rules.

OMB Control Number: 3060-0638.

Title: Section 76.934(g) Alternative rate regulation agreements.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 10,838.

Estimated Time Per Response: .5 hours.

Total Annual Burden to Respondents: 50 hours.

Total Annual Costs: $300.

Needs and Uses: This rule requires that local franchising authorities, certified pursuant to section 76.910, and small systems operated by small cable companies may enter into an alternative rate regulation agreements affecting the basic service tier and the cable programming service tier. Small systems must file with the Commission a copy of the operative alternative agreement within 30 days after its effective date. Alternative rate regulation agreements are filed with the Commission so that verification can be made the such agreements have been entered into and executed pursuant to the Commission rules.

Voluntary Customer Surveys of “Partners” for the Agency for Healthcare Research and Quality.

In response to Executive Order 12862, the Agency for Healthcare Research and Quality (AHRQ) plans to conduct voluntary customer surveys of “partners” to identify how well AHRQ is performing its functions with its partners and to use this information to determine the kind and quality of services they like and expect, their level of satisfaction with existing services, and to implement improvements where feasible and practical.

AHRQ partners are typically health care payers, plans, practitioners and providers, researchers, professional associations, AHRQ data suppliers, and State and local governments, as well as persons or entities that provide service to the public for AHRQ, e.g., dissemination of AHRQ publications by a “middle man” such as a professional society.

Partner surveys to be conducted by AHRQ may include surveys of research grantees to measure satisfaction with technical assistance received from AHRQ. The questions asked may include whether there is a need for extended hours to answer inquiries related to grant applications or for the development of a comprehensive manual on submission of grant applications. In addition, AHRQ wants to survey individual recipients of training grants to evaluate their experience with AHRQ training grant programs. Similarly, the Office of Health Care Information (OHCI) is proposing to survey researchers to determine how AHRQ could better serve the research community. Results of these surveys will be used to assess and redirect resources and efforts needed to improve services.

The data will be collected using a combination of preferred methodologies appropriate to each survey. These methodologies are:

• Mail and telephone surveys;

• Electronic technologies; and

• Focus groups.

The estimated annual hour burden is as follows:

In accordance with the above cited Paperwork Reduction Act legislation, comments on this AHRQ information collection proposals are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of the proposed information collection. All comments will become a matter of public record. Copies of the proposed collection plans and can be obtained from the AHRQ Reports Clearance Officer (see above).

“Medical Expenditure Panel Survey—Medical Provider Component (MEPS-MPC) for 2001 and 2002”

The MEPS-MPC is a survey of hospitals, physicians and other medical providers. The purposes of this survey is to supplement and verify the information provided by household respondents in the household component of the MEPS (MEPS-HC) about the use of medical services in the United States based on a nationally representative sample. With the permission of members of the households surveyed in the MEPS-HC, AHRQ contractor will contract the medical providers of the HC Survey respondents to determine the actual dates of service, the diagnoses, the services provided, the amount that was charged, the amount that was paid and the source of payment. Thus, the MPC is derived from or is based upon the core survey, (MEPS-HC) and will improve the quality of the core survey data.

The Medical Expenditure Panel Survey Household Component (MEPS-HC) to be conducted in 2001 through 2003, will provide annual, nationally representative estimates of health care use, expenditures, sources of payment and insurance coverage, for the U.S. civilian non-institutionalized population for 2001 and 2002 respectively. MEPS is co-sponsored by the Agency for Healthcare Research and Quality (AHRQ) and the National Center For Health Statistics (NCHS).

Data from medical providers linked to household respondents in the MEPS Household component for calendar year 2001, will be collected beginning in 2002 and continuing into the year 2003, data for calendar year 2002 will be collected beginning in 2003 and continue into the year 2004.

MEPS data confidentiality is protected under the NCHS and AHRQ confidentiality statutes, sections 308(d) and 924(c) of the Public Service Act [42 U.S.C. 242m(d) and 42 U.S.C. 299c-3(c) respectively].

The medical provider survey will be conducted predominantly by telephone, but may include self-administered mail surveys, if requested by the respondent.

The MPC for Calendar Year 2001 estimated annual hour burden is as follows:

The Secretary is required by section 1833(t)(9)(A) of the Social Security Act (the Act), as added by section 201(h)(1)(B) and redesignated by section 202(a)(2) of the Balanced Budget Refinement Act of 1999, to consult with an APC advisory panel. The panel will meet once annually to review the APC groups and provide technical advice to the Secretary and the Administrator of CMS concerning the clinical integrity of the groups and their associated weights. The technical advice provided by the panel at its annual meeting will be considered as CMS prepares the annual Notice of Proposed Rulemaking that will propose changes to the OPPS for the next calendar year.

The panel consists of 15 representatives of Medicare providers that are subject to the OPPS. The members were selected by the Administrator of CMS based upon either self-nominations or nominations submitted by providers or organizations.

The current members of the panel are: Michelle Burke, R.N.; Leslie Jane Collins, R.N.; Geneva Craig, R.N.; Lora A. DeWald, M.Ed; Gretchen M. Evans, R.N.; Robert E. Henkin, M.D.; Lee H. Hilborne, M.D.; Stephen T. House, M.D.; Kathleen P. Kinslow, CRNA, Ed.D; Mike Metro, R.N.; Gerald V. Naccarelli, M.D.; Beverly K. Philip, M.D.; Karen L. Rutledge, B.S.; William A. Van Decker, M.D.; and Paul E. Wallner, D.O. The panel Chairperson is Paul M. Rudolf, M.D., J.D., a CMS medical officer.

The agenda will provide for discussion and comment on the following topics:

• Reconfiguration of APCs, such as splitting of an APC and moving CPT codes from one APC to another.

• Consideration of the effects of using single versus multiple claims in setting relative weights.

• Consideration of guidelines for hospital billing of clinic visits and evaluation and management visits.

• Other technical issues concerning APC structure.

The panel will not be discussing the incorporation of the estimated cost of the pass-through devices into the base APC rates at this meeting.

For more detailed information on the agenda topics see our web site at http://www.hcfa.gov/fac/apcpage.htm.

Comments relating to this meeting must be received no later than 5 p.m. on Tuesday, January 8, 2002. Send comments to the following address: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attn: Valerie Barton, Mail Stop C4-05-17, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Comments may also be sent via electronic mail to outpatientpps@cms.hhs.gov. Because of staffing and resource limitations, we cannot accept comments by facsimile (FAX) transmission and cannot acknowledge or respond individually to comments we receive. Comments that are included in the agenda topics will be addressed in the proposed rule that will be published in the spring of 2002.

The meeting is open to the public, but attendance is limited to the space available. Individuals or organizations wishing to make oral presentations on the agenda items must submit a copy of the presentation and the name, address and telephone number of the proposed presenter. In addition, all presentations must contain, at a minimum, the following supporting information and data:

• Financial relationship(s), if any, with any company whose products, services, or procedures are under consideration;

• CPT codes involved;

• APC(s) affected;

• Description of the issue;

• Clinical description of the service under discussion, with comparison to other services within the APC;

• Description of the resource inputs associated with the service under discussion, with a comparison to other services within the APC;

• Recommendations and rationale for change; and

• Expected outcome of change and potential consequences of no change.

Further details can be found on our web site at http://www.hcfa.gov/fac/apcpage.htm. Presentations submitted without the required data and information will not be considered.

In order to be scheduled to speak, this information must be received no later than 5 p.m., Tuesday, January 8, 2002 at the above address. Alternatively, the information may be sent electronically to the email address specified above. Because of staffing and resource limitations, we cannot accept this information by facsimile (FAX).

Presentations are limited to no more than 5 minutes and must be on the listed agenda topics only. The number of presentations may be limited by the time available.

In addition to formal presentations, there will be an opportunity during the meeting for public comment, limited to 1 minute for each individual or organization. The number of speakers may be limited by the time available.

Any persons wishing to attend this meeting located on Federal property must call the meeting coordinator, Angela Mason, at (410) 786-7452 to register at least 72 hours in advance. Persons attending must show a photographic identification to the Federal Protective Service or Guard Service personnel before they will be allowed to enter the building. Persons not registered in advance will not be permitted into the building and will not be permitted to attend the meeting. News media representatives should contact the CMS Press Office at (202) 690-6145.

Individuals requiring sign language interpretation for the hearing impaired or other special accommodations should contact the meeting coordinator at least 10 days before the meeting.

The Balanced Budget Act of 1997 (BBA) (Public Law 105-33) established the Medicare+Choice program that significantly expanded the health care options available to Medicare beneficiaries. Under the BBA, the Secretary of the Department of Health and Human Services (the Secretary) must implement a risk adjustment methodology that accounts for variations in per capita costs based on health status and other demographic factors for payment to Medicare+Choice organizations (M+COs). The BBA also gives the Secretary the authority to collect inpatient hospital data for discharges on or after July 1, 1997, and additional data for other services occurring on or after July 1, 1998. Risk adjustment implementation began January 1, 2000. Payments to M+COs are made at 10 percent risk adjusted rates and 90 percent demographically adjusted rates for years 2000 through 2003. The Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act (BIPA), enacted in December 2000, stipulates that the risk adjustment methodology for 2004 and succeeding years should be based on data from inpatient hospital and ambulatory settings. BIPA contains a provision that phases in future risk adjusted payments as follows: 30 percent in 2004; 50 percent in 2005; 75 percent in 2006; and 100 percent in 2007. The collection of physician encounter data, which began on October 1, 2000, and hospital outpatient encounter data, which began on April 1, 2001, was suspended on May 25, 2001 through July 1, 2002. The Secretary indicated that we will be working closely with all interested parties to explore and implement a risk adjustment process for M+C payments that balances accuracy with administrative burden. The meeting will address the following topics:

• Risk adjustment models incorporating ambulatory and inpatient diagnoses;

• Collection/reporting of beneficiary and diagnostic information for Medicare+Choice enrollees in hospital inpatient, outpatient, and physician settings for use in risk adjustment models; and

• Data issues.

The agenda will include presentations by our staff and a question and answer sessions. Written public comments are preferred following the meeting and will be accepted until February 1, 2002.

Registration for this public meeting is required and will be on a first-come, first-serve basis, limited to two attendees per organization. A waiting list will be available for additional requests. The registration deadline will be January 11, 2002 at 5:00 pm. EST. Registration will be done via the Internet at http://www.hcfa.gov/events/events.htm. A confirmation notice will be sent to attendees upon finalization of registration.

Persons who are not registered in advance will not be permitted into the Federal Building and thus not be able to attend the meeting. Persons attending the meeting will be required to show a photographic identification, preferably a valid drivers' license before entering the building. Please note that if the meeting is cancelled we will post that information on our website.

Attendees will be provided with meeting materials at the time of the meeting. Written meeting materials will be posted on the CMS website before the January 16, 2002 meeting at: http://www.hcfa.gov and http://www.cms.hhs.gov. We will accept written questions about meeting logistics or requests for meeting materials either before the meeting or up to 14 days after the meeting. Written submissions must be sent to:

Aspen Systems Corporation, ATTN: Kim Slaughter, 2275 Research Boulevard, Mail Stop 5W, Rockville, Maryland 20850.

You may also contact Encounter Data Representative: Kim Slaughter, Telephone Number: (301) 519-5388, Fax Number: (301) 519-6360, E-mail: encounterdata@aspensys.com.

Written public comments will be accepted until February 1, 2002. Written public comments should be sent to Bobbie Knickman at bknickman@cms.hhs.gov or fax to (410) 786-1048.

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

FDA regulations require the distribution of patient labeling, called Medication Guides, for certain prescription human drug and biological products used primarily on an outpatient basis that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information. These Medication Guides inform patients about the most important information they should know about these products in order to use them safely and effectively. Included are information such as the drug's approved uses, contraindications, adverse drug reactions, and cautions for specific populations, with a focus on why the particular product requires a Medication Guide. These regulations are intended to improve the public health by providing information necessary for patients to use certain medication safely and effectively.

The regulations contain the following reporting requirements that are subject to the PRA. The estimates for the burden hours imposed by the following regulations are listed in table 1 of this document:

21 CFR 208.20—Applicants must submit draft Medication Guides for FDA approval according to the prescribed content and format.

21 CFR 314.70(b)(3)(ii) and 601.12(f)—Application holders must submit changes to Medication Guides to FDA for prior approval as supplements to their applications.

21 CFR 208.24(e)—Each authorized dispenser of a prescription drug product for which a Medication Guide is required, when dispensing the product to a patient or to a patient's agent, must provide a Medication Guide directly to each patient unless an exemption applies under § 208.26 (21 CFR 208.26).

Section 208.26(a)—Requests may be submitted for exemption or deferral from particular Medication Guide content or format requirements.

In the Federal Register of September 25, 2001 (66 FR 49024), the agency requested comments on the proposed collections of information. FDA received one comment on the September 25, 2001, notice. The comment stated that clarification is needed as to whether Medication Guides would be needed for medical devices that have a prescription drug either as a coating or incorporated into the material of the device, or as a component in a kit. The comment said that some of these types of products might be considered combination products.

FDA requested comments on the information collection burden estimates described in the notice. Because the comment does not pertain to the burden estimates, FDA has forwarded the comment to Docket Number 93N-0371, “Prescription Drug Product Labeling; Medication Guide Requirements.” FDA appreciates the comment and will consider it as part of its Medication Guide program.

In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in National Coalition for the Homeless v. Veterans Administration, No. 88-2503-OG (D.D.C.).

Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.

Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to Brian Rooney, Division of Property Management, Program Support Center, HHS, room 5B-41, 5600 Fishers Lane, Rockville, MD 20857; (301) 443-2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utili8ze a suitable property, providers should submit their written expressions of interest as soon a possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.

For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.

For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.

Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Clifford Taffet at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the Federal Register , the landholding agency, and the property number.

For more information regarding particular properties identified in this Notice ( i.e., acreage, floor plan, existing sanitary facilities, exact street address), providers should contact the appropriate landholding agencies at the following addresses: Army: Ms. Julie Jones-Conte, Headquarters, Department of the Army, Office of the Assistant Chief of Staff for Installation Management, Program Integration Office, Attn: DAIM-MD, Room 1E677, 600 Army Pentagon, Washington, DC 20310-0600; (703) 692-9223; GSA: Mr. Brian K. Polly, Assistant Commissioner, General Services Administration, Office of Property Disposal, 18th and F Streets, NW., Washington, DC 20405; (202) 501-0052; Interior: Ms. Linda Tribby, Acquisition & Property Management, Department of the Interior, 1849 C Street, NW., Washington, DC 20240; (202) 219-0728; (These are not toll-free numbers).

Through the Federal Aid in Sport Fish and Wildlife Restoration Program, the Service disburses funds to States in the form of grants to restore and manage the Nation's fish and wildlife resources. The States use the funds to conduct research, surveys and management; purchase and restore habitat; operate fish hatcheries; build boat access sites; and provide education, outreach and communications.

The Program is authorized by the Federal Aid in Sport Fish Restoration Act, 16 U.S.C. 777 et seq. , enacted in 1950 and the Federal Aid in Wildlife Restoration Act, 16 U.S.C. 669 et seq. , enacted in 1937. The Program's regulations can be found in Title 50 Code of Federal Regulations, part 80, “Administrative Requirements, Federal Aid in Fish and Federal Aid in Wildlife Restoration Acts;” Title 43 Code of Federal Regulations, part 12, “Administrative and Cost Principles for Assistance Programs;” and other applicable regulations. Various Office of Management and Budget (OMB) circulars, and guidance in the form of Service policy also apply to these chapters.

Funds for the Program are derived from excise and import taxes on fishing equipment, firearms, archery equipment and certain motorboat fuels paid into the Sport Fish Restoration Account or the Federal Aid to Wildlife Restoration Fund. The manufacturer or U.S. Customs (on imports) collects these taxes and pays it to the U.S. Department of the Treasury, who transfers the money to the Service for distribution to the States.

Periodically the Service conducts audits of our State partners, testing for compliance with applicable Acts, regulations, accounting principles, and Service policy. The purpose of these proposed chapters is to clarify the processes and guidelines for conducting an audit, from beginning through close-out of the audit process and resolution of any findings or other issues.

Generally our State partners are: The 50 States, the District of Columbia, the Commonwealths of Puerto Rico and the Northern Mariana Islands, Guam, the U.S. Virgin Islands, and American Samoa.

We are inviting comments on all chapters. Comments are welcome regarding completeness of the content of material in chapters; clear, easy to understand language; any burden placed on any Division of the Service, the Department of the Interior, or a State partner; or any other aspect of these documents. Comments must be written, but e-mailed comments are acceptable. The administrative record for this rule is available for viewing, by appointment only, Monday through Friday, 9 a.m. to 3 p.m., in the Division of Federal Aid, 4401 North Fairfax Drive, Suite 140, Arlington, Virginia 22203.

The draft chapters are as follows:

This chapter establishes policy and responsibilities for grantee audits, defines terms associated with audits, and provides an overview of the audit process. Other chapters in this Part (417) establish policy and procedures for audit scoping and planning, conducting and reporting, resolution, and appeals.

This Part applies to audits of grantees who receive grants through the Federal Aid Program.

We will:

A. Audit each grantee, once in each five-year period, as specified in the Wildlife and Sport Fish Restoration Programs Improvement Act of 2000. The Regional Director notifies the grantee(s), in writing, of the five-year audit schedule.

B. Provide adequate oversight and financial resources to ensure timely audit completion.

C. Cooperate and coordinate fully with grantees, auditors, the Office of the Inspector General (OIG), and Office of Financial Management (PFM).

The Federal Aid Audit Program supplements single statewide audits performed according to the requirements of OMB Circular A-133 (see 417 FW 6). The objectives of Federal Aid grantee audits are to:

A. Promote economy, efficiency, and effectiveness in administration of programs and operations.

B. Aid in the prevention and detection of fraud and abuse in programs and operations.

C. Assure financial integrity, accountability, and financial controls of the Federal Aid Program in accordance with generally accepted accounting principles.

D. Assure compliance with applicable Federal laws, rules, and regulations.

(1) Oversees the Federal Aid Audit Program.

(2) Makes the final decision on internal Service disagreements associated with resolving audit findings and preparing Corrective Action Plans (CAP).

(3) Makes the final decision on all grantee appeals to the Service.

(1) Ensure that Federal Aid Program staff receive the training necessary to oversee audits.

(2) Provide information to the auditor on Region-specific issues proposed for audit.

(3) Provide guidance and interpret laws, rules, regulations, and policies for the auditor during an audit.

(4) Work with the grantee and auditor throughout the audit to resolve issues as they arise and to identify those issues with potential national implications.

(5) Negotiate with grantees to develop corrective actions to resolve audit findings. Approve, distribute, and monitor implementation of the CAP.

(6) Request closeout of the audit when the grantee has resolved all findings.

(7) Maintain records pertaining to grantee audits, including the CAP and all appeals.

(1) Ensures consistent interpretation and application of rules, regulations, and laws concerning the Federal Aid Audit Program.

(2) Establishes the national audit schedule pursuant to the Wildlife and Sport Fish Restoration Programs Improvement Act of 2000.

(3) Coordinates Washington Office review of the CAP prior to signature by the Regional Director.

(4) Provides an objective representation of issues when there is a disagreement between the Regional Director and the Assistant Director on the CAP.

(5) Evaluates the Federal Aid Audit Program for efficiency, timeliness, and effectiveness prior to initiating each national audit cycle. The Assistant Director produces a written report at least once every five years, for the Director identifying issues and making recommendations for improving the Audit Program.

(1) Advises the Assistant Director—Migratory Birds and State Programs on scheduling of grantee audits. Coordinates audits and provides an independent auditor to conduct the audit.

(2) Ensures that audits are in accordance with Federal policies, regulations, and laws.

(3) Identifies national audit training needs and makes training available. Ensures that appropriate Washington Office Federal Aid Program staff receive the training necessary to oversee audits.

(4) Establishes the scope of the Audit Program in accordance with Government Auditing Standards (Yellow Book).

(5) Provides technical assistance on audit issues to the Regional Office staff and the Assistant Director—Migratory Birds and State Programs prior to and during the development of the CAP's.

(6) Coordinates with the Chief, Division of Policy and Directives Management and the OIG to determine appropriate means of responding to audit-related Freedom of Information Act (FOIA) requests and for distributing final audit reports and final CAP's.

(1) Oversees activities of the Service Audit Liaison Officer, who, in turn, serves as liaison to PFM and OIG regarding Federal Aid grantee audit followup.

(2) Advises Service officials on audit liaison matters.

(3) Tracks the implementation of audit recommendations and reports to the Directorate and PFM on grantee audit followup.

The Regional Director is responsible for maintaining audit resolution files in accordance with the Service's records schedule. The office or Region that administers the grant being audited will maintain the following documents in the audit resolution file:

A. All audit-related correspondence, incoming and outgoing.

B. OIG final audit report.

C. Approved CAP for both tracked and nontracked audit findings.

D. Documentation provided by the grantee and used by the Regional Director to verify that the grantee resolved each finding or implemented the auditor's recommendation.

E. Documentation that the audit has been officially closed out.

A deliberative process that the grantee initiates when he/she does not agree with the Regional Director's determinations, corrective actions, or the resolutions contained in the CAP.

Examination of Federal Aid Program grantees conducted by the Department of the Interior, OIG, other Federal agencies, and independent public accountants.

The OIG's designee to conduct the audit.

Specific action(s) to resolve an audit finding in a manner consistent with the Service determination.

Management's two-part plan for addressing all audit findings and implementing all recommendations contained in audit reports. The first part addresses all audit findings and recommendations identified in the OIG's transmittal memorandum with the final audit report. The second part, called the addendum, addresses all other audit findings in the final audit report not specifically identified in the OIG's transmittal memorandum. The audit resolution plan in each part contains four components: Auditor's Findings and Recommendations, Service Determination, Corrective Action, and Resolution.

Any report prepared by the auditor for review and comment by the Service or the grantee prior to issuance of the final audit report by the OIG.

The official notification of a pending audit from the auditor to the grantee.

The meeting involving the auditor, the Service, the grantee, and others, if needed, that officially begins the onsite portion of the audit.

The meeting involving the auditor, the Service, the grantee, and others, if needed, to review the draft audit report and end the field audit.

A Program that administers the responsibilities of the Secretary of the Interior under the Federal Aid in Sport Fish Restoration Act, Federal Aid in Wildlife Restoration Act, Clean Vessel Act, Coastal Wetlands Act, the Partnerships for Wildlife Act, and other Acts that establish grant programs. The Service's Division of Federal Aid fulfills these responsibilities.

Work that the auditor performs while on the grantee's premises or project sites.

The completion of all actions, including documentation, necessary to implement a specific audit recommendation and resolve an audit finding.

The auditor's final report of findings for an audit of a grantee, issued by the OIG. It includes the auditor's recommendations, the grantee's response to the draft audit report, and the auditor's rejoinder.

The entity to which the Service awards a grant and who is accountable for use of the Federal funds provided.

The Department of the Interior organization under the Assistant Secretary—Policy, Management and Budget that tracks audit recommendations to final action.

The Department of the Interior organization responsible for conducting, supervising, and coordinating audits, investigations, and other activities in the Department designed to promote economy and efficiency or prevent and detect fraud, waste, and abuse.

Helps to ensure that we conduct audits in an economical and efficient manner.

The auditor's answer to the grantee's response to an audit finding and recommendation.

A process to address and resolve each finding and recommendation in the audit report.

The process to identify programmatic and financial elements to be audited.

The Washington Office representative that serves as the point of contact for certain followup activities pertaining to grantee audits.

The Service decision to sustain (accept) or not sustain (reject) the auditor's finding and recommendation.

An audit of a grantee completed in accordance with the requirements of the Single Audit Act of 1984 and OMB Circular A-133. These audits are separate from Federal Aid Program specific audits (grantee audits).

As used throughout this Part, the terms we or us refer to the Fish and Wildlife Service.

During the scoping phase, the auditor identifies programmatic and financial elements to be audited, establishes the period to be audited, identifies issues of potential concern, and ensures that the audit meets Government standards. The planning phase helps to ensure a nationally consistent, effective, and timely audit process. Audit planning establishes the audit schedule, identifies who will conduct the audit, identifies point(s) of contact, sets milestones, and describes logistical requirements.

The audit conduct and reporting phase helps to ensure independent examination of grantees consistent with Government auditing standards.

The audit resolution phase ensures that all findings and recommendations are tracked and resolved in a timely and efficient manner.

The appeals process allows a grantee to appeal Service determinations, corrective actions, or resolutions.

Policy for resolving findings from audits conducted under the Single Audit Act.

This chapter describes the audit scoping and planning processes. See 417 FW 1 for authorities, responsibilities, and definitions. Other chapters in this Part establish policy and procedures for audit conducting and reporting, resolution, and appeals.

This process identifies the programmatic and financial elements to be audited.

The Chief, Division of Federal Aid (Washington Office) establishes the overall scope of grantee audits nationwide. Through discussions with the grantee and the auditor, Regional Directors help define the scope of specific audits. However, the auditor, supplementing and building upon other audits of the grantee, is responsible for identifying the depth and coverage of the audit.

An audit may include one or more of the following components.

A. A financial compliance component to determine if:

(1) A grantee properly conducts financial operations,

(2) Financial reports conform with generally accepted accounting principles, and

(3) Operations comply with applicable laws and regulations.

B. A component to determine whether or not the grantee accomplished the work approved in the grant.

C. An economy and efficiency component to determine whether or not the grantee efficiently and economically managed resources; e.g., personnel, property, space, etc.

After consulting with the Chief, Division of Federal Aid (Washington Office), the Regional Director, and the grantee about the appropriate time frames for the audit, the auditor schedules a pre-audit coordination meeting with the Regional Director to: (1) Define the period of the audit, identify specific concerns, and (2) to become familiar with grants that were active during the audit period.

The auditor contacts the audit agency or group that performed the Statewide audit to obtain access to audit work papers. The auditor reviews prior audits of the grantee's program to: (1) Aid in identifying issues to be evaluated, (2) obtain a general understanding of the grantee's accounting and internal control systems; and (3) avoid duplication of effort.

The auditor is responsible for notifying a grantee of a pending audit. The auditor sends an engagement letter to the grantee, with a copy to the Regional Director, at least 30 calendar days prior to the audit entrance conference. This letter informs the grantee of the audit objectives, the audit period, the key program elements being audited, the information and documents the grantee must make available, and the logistical needs for conducting the field audit.

No. An audit is an independent examination of the grantee's Federal Aid Program.

Yes. Using Government Auditing Standards, the auditor is required to review corrective actions from prior audits to determine if the grantee has implemented them or if additional actions are needed.

Yes. The scope of the audit may change when new information becomes available as the audit progresses. We expect the depth and coverage of work to change throughout the course of the audit. This is a routine aspect of the audit, not a change in scope. The most significant change in scope that we normally encounter is the need to change the period being audited.

The auditor provides a written recommendation to change the audit period to the Chief, Division of Federal Aid (Washington Office). The Chief, in consultation with the Regional Director, determines whether or not to change the audit period. The Regional Director provides the grantee written notification of any change in the period and the reason for the change.

Audit planning helps to ensure that we have a nationally consistent, effective, and timely audit process. Audit planning establishes the audit schedule, identifies who will conduct the audit, identifies point(s) of contact for the grantee, sets audit milestones, and describes logistical requirements. The auditor coordinates with the grantee and Service representatives during audit planning.

The Assistant Director—Migratory Birds and State Programs ensures collaboration among Service staff, the auditor, and the grantee by monitoring audit progress through the Chief, Division of Federal Aid (Washington Office).

The grantee will acknowledge the auditor's engagement letter within 30 calendar days providing as much information as possible. See paragraph 2.13.

Prior to starting the field audit, the auditor meets with Service Regional Federal Aid staff to discuss specific program audit concerns. Regional Federal Aid staff solicit grantee input during this process.

The grantee acknowledges the auditor's engagement letter by providing a written response, including as much requested data as is practical at that time. The grantee notifies the auditor of any information that is not available and estimates the date when the information will be available or explains why he/she cannot provide the information. Auditor review of data prior to arriving onsite will help to ensure a more timely and efficient onsite audit with minimal disruption of the grantee's normal operations.

This chapter provides procedures for conducting and reporting on audits of Federal Aid Program grantees. See 417 FW 1 for authorities, responsibilities, and definitions. Other chapters in this Part establish policy and procedures for audit scoping and planning, resolution, and appeals.

To ensure independent examination of grantees consistent with Government auditing standards. This examination results in a final audit report issued by the OIG.

This meeting marks the official beginning of the field audit.

Field audits usually take three to four months to complete, including site visits. The auditor, the grantee, and the Regional Director communicate regularly to resolve potential audit findings and recommendations before the auditor prepares the draft audit report.

Following the field audit, the auditor prepares a draft audit report for review by the Chief, Division of Federal Aid (Washington Office) and the Regional Director. This review may result in revisions or requests for further audit work before the draft audit report is provided to the grantee.

After the auditor releases the draft audit report, he/she schedules an audit exit conference with the Regional Director and the grantee. This conference provides an opportunity for the grantee and Service representatives to ask for or provide further clarification as well as to address any other concerns. The conclusion of the conference marks the completion of the field audit.

The auditor includes both the grantee's response and the auditor's rejoinder in the draft audit report, and submits the report to the OIG for review and approval.

If the OIG accepts the auditor's draft audit report, the OIG assigns an OIG number to the audit report and issues the report to the Regional Director.

The auditor schedules this conference in consultation with the grantee and the Regional Director to mark the official beginning of the field audit. Participants include the auditor and representatives from the grantee and the Region. The auditor will explain the audit objectives and process, address logistical needs, establish a tentative schedule, and answer questions.

The Regional Director provides guidance and interprets laws, rules, regulations, and policies for the auditor during the conduct of the audit. The Assistant Director—Migratory Birds and State Programs ensures consistent interpretation and application of rules, regulations, and laws nationwide.

Yes. During the field audit, the auditor provides monthly status reports to the Regional Director and the Chief, Division of Federal Aid (Washington Office). The status report contains a brief description of preliminary findings and how the audit is progressing.

The Regional Director forwards a copy of the status report to the grantee and maintains a copy in the audit file. If the Regional Director or the Chief, Division of Federal Aid (Washington Office), has a concern about potential findings by the auditor, he/she contacts the Assistant Director, the auditor, or the grantee to deal with the issue(s) as soon as practicable. If the Regional Director or the Chief believe that an issue is of national concern, he/she notifies the Assistant Director—Migratory Birds and State Programs. The Assistant Director determines the appropriate action for national application and issue resolution and issues written guidance to the Regional Directors where the issue is relevant.

No. The auditor's monthly status reports are proprietary, and we will share these reports with the grantee only.

Yes. The auditor must report all potential findings to the Regional Director as soon as possible or at least monthly in the status reports. However, in the case of illegal activity or suspected fraud, the auditor must immediately report such findings to the OIG.—Division of Investigations without notice to the Service.

Yes. When practical and feasible, we work with grantees to resolve audit findings while the auditor is still onsite so that he/she can verify and document the resolution in audit work papers, and report the resolution in the final audit report. The auditor must document all reportable conditions, including those resolved during the audit, to meet Government Auditing Standards.

Yes. Following the field audit, the auditor prepares a draft audit report for review by the Assistant Director—Migratory Birds and State Programs and the Regional Director. We have 30 calendar days from receipt of the draft audit report to complete this review. This review may result in revisions or request for further audit work. After the review is complete, the Regional Director will provide the draft audit report to the grantee at least 30 calendar days prior to the audit exit conference.

The auditor schedules the audit exit conference with the Service and the grantee, to occur on a mutually agreeable date. This conference is a formal opportunity for the grantee and the Service to request or provide further clarification on the potential findings and to address any other concerns relating to the conduct of the audit and the draft audit report. Participants include the auditor and representatives of the Service and the grantee.

Yes. The auditor takes information received during the exit conference under advisement. The auditor may modify the findings or recommendations before submitting the draft audit report to the OIG.

Yes.

A. After the exit conference, the grantee has 30 calendar days to:

(1) Concur with the audit findings and recommendations, or

(2) Disagree with audit findings or recommendations, and provide additional information, if appropriate, to support the grantee's position on specific audit findings.

B. The auditor will summarize the grantee's response in the final report and include the complete text of the grantee's response as an attachment. The grantee may ask the Regional Director for additional review time. This written request must include supporting justification. The Regional Director responds to the grantee's request and instructs the auditor and the grantee accordingly, in writing.

Yes. The auditor answers the grantee in the draft audit report in the auditor's rejoinder.

After the grantee's response and the auditor's rejoinder are incorporated, the auditor submits the draft audit report to the OIG.

After reviewing the auditor's draft audit report, the OIG issues the final audit report to the Regional Director via a transmittal memorandum. The auditor sends copies of the report to the Chief, Division of Federal Aid (Washington Office), the Service Audit Liaison Officer, and all other Regional Directors.

The Regional Director transmits a copy of the final audit report to the grantee within 10 working days of receipt of the report from the OIG.

The OIG originates the final audit report and is responsible for distribution. The Regional Director may, with permission from the OIG, distribute this report to the public, but only after the grantee has received the report. The grantee may release the report at its discretion.

The Chief, Division of Federal Aid (Washington Office) will coordinate with the Chief, Division of Policy and Directives Management, and the OIG to determine if posting a specifically requested document on the Internet is appropriate.

This chapter establishes policy and procedures for tracking and resolving findings and implementing recommendations from audits of Federal Aid Program grantees. See 417 FW 1 for authorities, responsibilities, and definitions. Other chapters in this Part establish policy and procedures for audit scoping, planning, conducting and reporting, and appeals.

The formal audit resolution process begins on the date the OIG issues the final audit report. However, the Regional Director will work with the grantee while the audit is in progress to resolve issues that the auditor identifies. Exhibit 1 provides the maximum time frames for each phase of the audit resolution process.

The OIG's transmittal memorandum transmits the final audit report to the Service and is the document of record for identifying the audit findings that we must address specifically in the CAP and report to the OIG.

The Regional Director and the grantee negotiate the terms of the CAP through written and oral discussions of the auditor's findings and recommendations, the grantee's response, the auditor's rejoinder, and the Service's determination. The Regional Chief, Division of Federal Aid, in coordination with the grantee and the Washington Office Division of Federal Aid, prepares the CAP for the Regional Director's signature.

The Service has 90 calendar days from the date the OIG issues the final audit report to resolve all audit findings with the grantee and to prepare the CAP.

Either we or a grantee may need additional time to gather information necessary to develop the CAP. Requests are made as follows:

A. If the grantee needs an extension, he/she must notify the Regional Director in writing at least 15 calendar days prior to the 90 calendar day deadline and provide a justification for the extension.

B. We can make one request to the OIG for 30 additional calendar days to prepare the CAP. If the Regional Director requests additional time, he/she will explain why the additional time is necessary and provide a copy of the request to the grantee.

A. Include a cover page that clearly identifies the grantee audited, the years audited, and the report number. Obtain this information from the title of the OIG's final audit report.

B. The CAP contains two parts. The first part addresses all audit findings and recommendations that the OIG identifies in the transmittal memorandum. The second part, called the addendum, addresses any other findings in the final audit report. Each part contains:

(1) Auditor's Findings and Recommendations. The OIG reports these for resolution. The OIG's transmittal memorandum identifies questioned costs or procedures and the auditor's recommendations that we must address in the CAP. It assigns titles and numbers to the auditor's recommendations for tracking in the CAP.

(2) Service Determination. The Service sustains (accepts) or does not sustain (rejects) the auditor's finding and recommendation. Sustained recommendations from the final audit report must result in planned corrective actions. If the Regional Director does not sustain an audit finding, he or she explains the basis, including legal citations, for that determination. The CAP addresses both sustained and nonsustained findings.

(3) Corrective Action. This component identifies specific corrective action(s) to resolve the finding consistent with the Service Determination. It specifies necessary actions, target dates, and the person responsible for carrying out each action. It also specifies how the grantee should implement the corrective actions to resolve the issues.

(4) Resolution. This component describes documentation that we require of the grantee to verify implementation of the corrective action(s) and target dates.

The Assistant Director—Migratory Birds and State Programs will review the draft CAP and decide whether to concur or not concur within 30 calendar days from the date the Region forwards the CAP to the Washington Office.

The Assistant Director will work with the Regional Director to resolve any disagreements with the CAP. If they cannot resolve their differences, the Director will make the final decision. The Assistant Director may request a 30 calendar day extension from the OIG if needed and if we have not requested a previous extension.

The Assistant Secretary for Policy, Management and Budget is the audit followup official for the Department of the Interior and makes final determination on audit resolution. The Office of Financial Management (PFM) is the Departmental office delegated authority by the Assistant Secretary to deal with audit resolution. The PFM notifies the Director whether or not it concurs with the Service's determination.

No.

A. The OIG identifies the recommendations that we must resolve and describes them in the final audit report transmittal memorandum. If we have not resolved the identified recommendations within the 90 calendar days specified in the memorandum (or 120 calendar days if an extension has been granted), the OIG will refer them to PFM for tracking. The PFM reports back to the OIG when those recommendations are resolved.

B. Nontracked audit recommendations are all other recommendations in the final audit report. We do not report resolution of nontracked recommendations to the OIG. However, the Regional Director is responsible for resolving all audit recommendations-both tracked and nontracked.

The Regional Director negotiates and documents resolution of nontracked recommendations in the CAP addendum. The addendum follows the same format as part 1 of the CAP. The Regional Director retains the addendum and tracks corrective actions outlined therein. Resolution and issue closure documentation must meet the same standards as those described for part 1. These records are retained in Regional Federal Aid audit files. A grantee may appeal the actions contained in the CAP addendum by initiating the process described in 417 FW 5.

The corrective action for each finding has a specific deadline as negotiated during development of the CAP. A grantee may request additional time from the Regional Director. The request must be in writing and justify the time requested. The Regional Director responds in writing within 10 working days and copies the Chief, Division of Federal Aid (Washington Office). The Chief notifies the Audit Liaison Officer of the change.

The Regional Director monitors, tracks, and documents implementation of the CAP and keeps the Director, through the Chief, Division of Policy and Directives Management, informed of implementation progress.

Within 2 weeks of the Washington Office decision, the Regional Director signs and forwards the CAP,

A. Excluding the addendum, to the OIG, and

B. Including the addendum, to the grantee for implementation, and provides a copy to the Chief, Division of Federal Aid (Washington Office).

The Regional Director originates the CAP and makes it available to the public upon request, but only after the grantee has received a copy. A grantee may release a copy of the CAP at his or her discretion.