INFORMATION COLLECTION REQUEST FOR REGULATORY INCENTIVES DESIGNED FOR EPA'S NATIONAL ENVIRONMENTAL PERFORMANCE TRACK PROGRAM No. 1949.03 August 6, 2004 Prepared by:

U. S. Environmental Protection Agency Office of Policy, Economics, and Innovation 1200 Pennsylvania Avenue NW Washington, D. C. 20460 TABLE OF CONTENTS 1. Identification of the Information Collection ........................................................................ 1 1( a) Title of the Information Collection...................................................................................... 1 1( b) Background ........................................................................................................................ 1 1( c) Short Characterization/ Abstract .......................................................................................... 1 2. Need for and Use of the Collection ....................................................................................... 4 2( a) Need/ Authority for the Collection....................................................................................... 4 2( b) Use/ Users of the Data ......................................................................................................... 5 3. Non duplication, Consultations, and other Collection Criteria .......................................... 5 3( a) Non duplication.................................................................................................................. 5 3( b) Public Notice required prior to ICR submission to OMB .................................................... 5 3( c) Consultations ...................................................................................................................... 5 3( d) Effects of Less Frequent Collection .................................................................................... 6 3( e) General Guidelines ............................................................................................................. 6 3( f) Confidentiality .................................................................................................................... 6 3( g) Sensitive Questions ............................................................................................................ 6 4. The Respondents and the Information Requested............................................................... 6 4( a) Industry Respondents/ SIC Codes ........................................................................................ 6 4( b) Information Requested from Industry Respondents............................................................. 6 ( i) Data items, including record keeping requirements ....................................................... 6 ( ii) Industry Respondent Activities ..................................................................................... 9 4( c) State/ Local Agencies .......................................................................................................... 9 4( d) Information Requested from State/ Local Agencies ............................................................. 9 ( i) Data items, including record keeping requirements ........................................................ 9 ( ii) State/ Local Agency Activities..................................................................................... 10 5. The Information Collected  Agency Activities, Collection Methodology, and Information Management ............................................................................................... 11 5( a) Agency Activities ............................................................................................................. 11 5( b) Collection Methodology and Management........................................................................ 11 5( c) Small Entity Flexibility..................................................................................................... 12 5( d) Collection Schedule.......................................................................................................... 12 6. Estimating the Burden and Cost of the Collection ............................................................ 12 6( a) Estimating Industry Respondent Burden ........................................................................... 12 6( b) Estimating Industry Respondent Costs.............................................................................. 13 ( i) Estimating Labor Costs............................................................................................. 13 ( ii) Estimating Capital and Operations and Maintenance Costs ....................................... 13 iii 6( c) Estimating State/ Local Agency Burden and Cost ............................................................... 13 6( d) Estimating Agency Burden and Cost ................................................................................. 14 6( e) Estimating the Respondent Universe ................................................................................. 14 6( f) Bottom Line Burden Hours and Cost ................................................................................. 15 ( i) Industry Respondent Tally ......................................................................................... 15 ( ii) State/ Local Tally ....................................................................................................... 18 ( iii) Agency Tally............................................................................................................. 20 ( iv) Variations in the Annual Bottom Line........................................................................ 22 6( g) Reasons for Change in Burden.......................................................................................... 22 6( h) Burden Statement ............................................................................................................. 22 Index of Tables Table 1.1 Projected Membership Levels and Incentive Eligibility ............................................. 3 Table 1.2 Summary of Facility Burden Estimate for Performance Track Rule ............................ 4 Table 4.1 Primary NAICS Codes of Current Performance Track Members ................................ 7 Table 6.1 Hourly Labor Rates for Industry Respondents .......................................................... 13 Table 6.2 Hourly Labor Rates for State/ Local Agency Respondents......................................... 14 Table 6.3 Hourly Labor Rates for EPA..................................................................................... 14 Table 6.4 Industry Respondent Burden, 2004 2006.................................................................. 16 Table 6.5 State/ Local Agency Burden, 2004 2006 ................................................................... 18 Table 6.6 EPA Burden, 2004 2006........................................................................................... 20 Table 6.7 Aggregate Burden, 2004 2006.................................................................................. 23 Table 6.8 OMB 83 I Reportable Aggregate Burden, 2004 2006............................................... 28 0 PART A OF THE SUPPORTING STATEMENT 1. Identification of the Information Collection 1( a) Title of the Information Collection  Implementation of Incentives Designed for EPA's National Environmental Performance Track program ( Performance Track, or PT).

1( b) Introduction ICR 1949.03 presents the burden hours and costs associated with the Performance Track rule ( PT Rule) that was promulgated on April 22, 2004 ( 69 FR 21737). The PT Rule makes changes to the regulatory system under the Resource Conservation and Recovery Act ( RCRA), and the Maximum Achievable Control Technology ( MACT) standards under the Clean Air Act. EPA has developed numerous ICRs under these programs. The changes made by the PT Rule potentially affect many of these individual ICRs, particularly the ICRs for the MACT program of which there are several score. For an ICR such as todays, EPA typically would develop a change worksheet, an OMB 83 C form, that would reallocate burden hours across existing program specific ICRs. However, EPA has decided not to amend the numerous ICR's with 83 Cs in order to reduce the process burden for both the Office of Management and Budget ( OMB), and EPA. EPA believes it would require developing scores and scores of 83 Cs each of which would provide de minimus hour and cost adjustments. Due to the high numbers of 83 Cs and the associated administrative burden and the low burden hour revisions associated with each, EPA presents OMB with this amendment to characterize the burden and cost of EPA regulatory action. EPA notes that its program offices will have the opportunity to amend their burden hour estimates as specific ICR's for programs are renewed. Finally, as required by OMB in the 83 I form, today's ICR presents only additional ( positive) burden hours. The current OMB inventory for the Performance Track program is 109,661 hours as amended in ICR 1949.04 ( Approved by OMB 6 22 04). This amendment adds 3,778 new hours for a total of 113,439.

The supporting statement analysis for EPA's regulatory action demonstrates a moderate increase of burden hours, and a significant reduction in labor costs. Further, EPA notes that these savings do not appear in the 83 I summary form, yet they represent a more accurate accounting of the true burden and cost estimate of this regulatory action. The significant hours that are not reported are as follows: reduction of respondents hours and costs:  11,300 hours; $ 632,000. Total net hours and net costs for respondents and States are: 2,620 hours; $ 456,490. Total net burden hours and costs for respondents, States and EPA are: 3,223 hours; $ 197,674. These figures may be found in Table 6.7, on the last page of this document.

1( c) Short Characterization/ Abstract  This is a new collection ICR No. 1949.03 to estimate burden hours resulting from a new EPA regulation promulgated for members of the National Environmental Performance Track Program. 1 The Environmental Protection Agency developed the Performance Track program to motivate and reward facilities that achieve better environmental performance than is required under existing regulations. This program enhances the current regulatory system by offering 1 ICR No. 1949.02, National Environmental Performance Track, addresses the application and annual report requirements for the Performance Track Program. 1 recognition, regulatory, and other incentives to facilities that have demonstrated a commitment to performing better than compliance with environmental regulation. In the program description, EPA committed to propose specific regulatory changes as incentives for participation in the Performance Track program. The changes finalized follow up on this commitment. EPA believes the modest regulatory changes finalized are appropriate for facilities that are accepted into the program. In some cases, states must take additional steps before a facility may take advantage of an incentive. For example, responsibility for implementing parts of many environmental programs is delegated to states. In such cases, states may need to revise regulations, agree on a revised delegation or authorization package, or take other actions.

In deciding which regulatory changes to include in the final rule, EPA focused on those incentives that would apply broadly to different types of facilities; that reduce the reporting and other operating costs of the current regulatory system; and that can be implemented nationally. EPA specifically excluded incentives that would involve a relaxation of substantive standards of performance or that would require statutory change.

The following summarizes the RCRA and MACT regulatory changes that offer incentives to Performance Track facilities:

$ Reducing the frequency of reports required under the Maximum Achievable Control Technology ( MACT) provisions of the Clean Air Act. Through this incentive, EPA reduced the frequency of MACT reporting for all Performance Track facilities to which these requirements apply. EPA also further reduced reporting requirements for Performance Track facilities that achieve MACT or better emission levels through pollution prevention methods.

$ Allowing large quantity hazardous waste generators participating in the Performance Track program up to 180 days ( and 270 days if the waste is transported 200 miles or more) to accumulate hazardous waste without a RCRA permit or interim status, provided that these generators meet certain conditions.

The incentives described in the rulemaking are part of a broader package of incentives that EPA continues to develop for Performance Track program participants.

Performance Track facilities eligible for the incentives contained in the final rulemaking voluntarily determine whether to avail themselves of these incentives. The rulemaking changes finalized reduce reporting and other compliance costs for affected facilities. Most of thee cost reductions result from reduced waste management costs or reduced respondent reporting burden hours. These changes also reduce the total number of such hours resulting from EPA's regulatory programs.

As of December 2003, EPA completed the first six membership enrollment periods for the Performance Track program. This resulted in a total of 309 facilities ( mostly industrial, but also a number of facilities in the service sector, and several federal facilities). EPA estimates that of the current Performance Track membership, 93 facilities are eligible to take advantage of the MACT incentive, while 125 facilities are eligible to take advantage of the RCRA incentive. 2 This results in a total of 175 Performance Track facilities that are eligible to take advantage of one or more of the incentives contained in today's final rule, with 43 facilities being eligible for both the MACT and RCRA incentives. The Agency estimates that 295 additional facilities will join the Performance Track program during the three year period covered by the ICR ( i. e., 2004 2006).

EPA anticipates that the incentives promulgated will yield significant cost and burden hour savings over the ICR period. The Agency estimates that the annual burden reduction per facility for Performance Track facilities availing themselves of the MACT incentive is 25.5 hours with cost savings of $ 1,427.22. EPA estimates that eligible facilities transporting waste for treatment/ disposal will expend 8.9 hours of labor annually with costs of $ 445.40. In all three years, these costs are adjusted to reflect transportation cost savings resulting from the additional accumulation time provided in the RCRA incentive. EPA projects that member facilities will experience net RCRA costs of $ 4,730 in 2004; members will experience net RCRA cost savings of $ 35,306 and $ 44,012 in 2005 and 2006, respectively ( See Table 6.4 for more detail). Based on the 309 facilities currently in the program and EPA's projections of future membership levels and incentive eligibility, the total impact of the final rule yields an estimated cost savings ranging from $ 160,826 in 2004 to $ 303,766 in 2006; and an annual burden hour savings ranging from 1584.4 hours in 2004 to 3546.5 hours in 2006. These figures are based on the number of Performance Track facilities eligible for the incentives, and dependent upon whether such facilities elect to avail themselves of the incentives. EPA anticipates that additional facilities will join the Performance Track program in the future and experience similar annual changes in costs and burden hours on a per facility basis. Table 1.1 below details EPA's projections of membership levels and incentives eligibility over the period covered by this ICR.

Table 1.1 PROJECTED MEMBERSHIP LEVELS AND INCENTIVE ELIGIBILITY Current 2004 2005 2006 Membership 1 309 386 483 604 MACT Incentive 2 93 116 145 182 RCRA Incentive 3 125 156 195 244 RCRA: 200 mile4 6 8 9 12 Total facilities in MACT and RCRA 218 272 340 426 Number and Percent of facilities in both MACT and RCRA 43/ 20% 20% = 54 20% = 68 20% = 85 Total eligible facilities MACT and RCRA 5 175 218 272 341 Mean number of eligible facilities 2004 2006, use for 83 I 6 277 3 Notes: 1The Performance Track program estimates a 25 percent annual growth rate in membership. See ICR No. 1949.02, National Environmental Performance Track Program. This renewal of the program ICR is active until August 2006, and will be posted at http:// www. epa. gov/ icr/ icrlist. html.

2 Performance Track facilities likely to be eligible for the MACT incentive include those members permitted as minor or synthetic minor air sources and in a NAICS sector likely to be subject to a MACT requirement. An analysis of EPA's IDEA database yielded 106 potential minor or synthetic minor air sources. See http:// www. epa. gov/ compliance/ planning/ data/ multimedia/ idea/ index. html. EPA then screened out 13 Performance Track members in sectors unlikely to be subject to MACT requirements ( i. e., nine members in the Public Facilities and Institutions sector; two members in the Mining and Construction sector; and two members in the Wholesale Retail and Shipping sector). This analysis resulted in 93 eligible facilities in the current membership. EPA estimates the annual increase in Performance Track members likely to be eligible for the MACT incentive by applying the percentage eligible among the current membership ( i. e., 30 percent) to subsequent years.

3 Analysis of the 2001 Biennial Reporting System database indicates that 125 current Performance Track members are Large Quantity Generators ( LQGs). See http:// www. epa. gov/ epaoswer/ hazwaste/ data/ index. htm. EPA estimates the annual increase in LQG Performance Track members by applying the percentage eligible among the current membership ( i. e., 40 percent) to subsequent years.

4 To estimate the number of Performance Track LQGs that may be located more than 200 miles from a hazardous waste treatment/ disposal facility, EPA applied a GIS screening analysis to map all current Performance Track LQGs and all TSDFs that received waste in the 2001 reporting year. EPA then applied a 200 mile radius to each Performance Track LQG to determine the overlap. Based on this analysis, it appears that very few current Performance Track members are located more than 200 miles from a hazardous waste treatment/ disposal facility and thus the Agency assigned a five percent probability that Performance Track members would be likely to ship their waste more than 200 miles; the remaining 95 percent of members are assumed to accumulate waste for 180 days and ship within 200 miles. EPA believes this to be a reasonable percentage based on the prevalence of Performance Track members and waste treatment/ disposal facilities in industrialized regions of the country. Furthermore, our analysis was not able to correlate specific Performance Track members with specific waste handling facilities. Therefore, it may be the case that a Performance Track member would need to ship its waste more than 200 miles in cases where a waste characterization requires treatment/ disposal at a facility permitted to receive such waste.

5 Total eligible facilities MACT and RCRA. As described on page 3, there are 43 facilities that are eligible for both the RCRA and MACT incentives. This percentage was used for subsequent years to develop the estimates for 2004  2006.

6 Mean number of eligible facilities 2004 2006, used for 83 I was determined by calculating the mean values from years 2004 through 2006.

Not all of these savings will be available immediately upon promulgation of the rulemaking because of the time required for states to pursue authorization of the rules from EPA. The Agency estimates that the full resource savings described above will begin to be realized about two years after the rulemaking's promulgation or after the relevant state rule revisions can be promulgated. Finally, these rulemaking changes will result in some increased administrative costs for EPA itself. Table 1.2 summarizes the facility burden estimate for the implementation of incentives designed for EPA's Performance Track program. 4 Table 1.2 SUMMARY OF FACILITY BURDEN ESTIMATE FOR PERFORMANCE TRACK RULE 1 Facility Burden, 2004 2006 Information Collection Activity Hours/ Facility Cost/ Facility Total Hours2 Total Cost3 MACT Provisions 2004  25.5 $ 1,427.22  2958.0 $ 165,557.52 2005  25.5 $ 1,427.22  3697.5 $ 206,946.90 2006  25.5 $ 1,427.22  4641.0 $ 259,754.04 MACT Subtotal  76.5 $ 4,281.66  11296.5 $ 632,258.46 RCRA Provisions 2004 8.9 $ 445.40 1373.6 $ 68,564.18 2004 RCRA Savings n/ a 4 $ 368.98 n/ a $ 63,833.54 2005 8.9 $ 445.40 873.7 $ 44,393.35 2005 RCRA Savings n/ a $ 368.98 n/ a $ 79,699.68 2006 8.9 $ 445.40 1094.5 $ 55,612.33 2006 RCRA Savings n/ a $ 368.98 n/ a $ 99,624.60 RCRA Subtotal 26.7 $ 229.26 3341.8 $ 74,587.96 Final Rule ( MACT and RCRA) 2004  16.6 $ 1,350.80  1584.4 $ 160,826.88 2005  16.6 $ 1,350.80  2823.8 $ 242,253.23 2006  16.6 $ 1,350.80  3546.5 $ 303,766.31 Total Burden  49.8 $ 4,052.41  7954.7 $ 706,846.42 Notes: 1Table 6.4 provides detailed annual breakdowns for 2004 through 2006. For example, requirements associated with the MACT incentive occur on an annual basis; whereas the RCRA incentive requires certain one time events ( e. g., prior written notification of intent to accumulate; contingency plan amendment; and 200 mile certification, if applicable) and an annual requirement to document any impacts of additional accumulation time in the facility's annual Performance Track report. In addition, there will be annual cost savings for each facility availing itself of the RCRA incentive. Such savings are realized on a per waste stream ( rather than a perfacility basis. This Summary Table 1.2 aggregates data by year and distinguishes, for RCRA provisions, between costs and cost savings. 2Calculated by multiplying the labor hours ( or labor hour savings) per facility by the number of eligible facilities. 3Calculated by multiplying the labor cost ( or labor cost savings) per facility by the number of eligible facilities. 4RCRA savings result from transportation efficiencies in shipping waste; EPA does not include facility burden hour reductions in these estimates.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection  EPA's National Environmental Performance Track program is committed to providing incentives to the environmental leaders who are members of the program. Some of the incentives contained in this final rulemaking will reduce the facilities' regulatory burden by reducing reporting requirements and reducing the costs of hazardous waste transport. EPA views these incentives as a way to reward current Performance Track members and to encourage additional participants in a program that promotes the use of 5 environmental management systems, continuous environmental improvement, public participation, and performance reporting.

2( b) Use/ Users of the Data  Each facility's notifications and reports to the Agency will be used by EPA and participating regulatory entities to monitor the facility's compliance with the incentives finalized today, and to determine whether the facility continues to be eligible for the incentives.

3. Non duplication, Consultations, and other Collection Criteria 3( a) Non duplication  The information to be obtained under this ICR has not been collected by EPA or any other state or local agency.

3( b) Public Notice required prior to ICR submission to OMB  The proposed rule was published in the Federal Register prior to submitting a draft ICR to OMB for review; this ICR accompanies the final rule. The proposed and final rules address Paperwork Reduction Act requirements.

3( c) Consultations  EPA has partnered with states, Performance Track member facilities including the Performance Track Participants Association, and the Performance Track Network to develop incentives to reward Performance Track members for their top performance and to motivate other facilities to implement environmental improvements that would qualify these facilities for meeting the eligibility criteria of the program. In addition, EPA convened a series of public meetings to obtain input as the Agency developed the program.

Today's final rulemaking grew out of the stakeholders' collective interest in promoting incentives for participating facilities. Since the inception of the program, EPA has held four meetings with state regulators in May 2000 in Denver, February 2001 in Chicago, November 2001 in Charleston, January 2003 in Denver, and February 2004 in Washington, D. C. At each of these meetings, EPA solicited feedback on potential Performance Track incentives through break out sessions with state personnel.

In addition, EPA has consulted regularly with individual Performance Track participants and the Performance Track Participants Association ( PTPA). Comprising 164 Performance Track member facilities, the PTPA is a nonprofit organization that provides a forum for corporations, trade associations and public entities dedicated to improving their environmental performance through the Performance Track Program. The PTPA met twice in June and November of 2001, convened its first annual conference in April 2002, and recently held an annual meeting in Dallas in November 2003. The PTPA also has an Incentives workgroup that focuses on identifying and advocating for incentives for Performance Track members. EPA also works with 22 member organizations through the Performance Track Network to further enhance participation in the program.

Finally, a Performance Track workgroup assisted with the internal review of the proposed and final rulemakings. The workgroup comprised representatives from each relevant EPA 6 Program Office, as well as representatives from EPA's Office of Enforcement and Compliance Assurance ( OECA), Office of General Counsel ( OGC), and Office of Environmental Information ( OEI). Regional Performance Track contacts were briefed on the development of the regulatory package on a periodic basis. Program office representatives enlisted additional Program staff on an as needed basis to work through issues and refine the regulatory language.

3( d) Effects of Less Frequent Collection  For the most part, today's final rule reduces the reporting burden for Performance Track members. The information requested by the rule will help EPA to determine whether Performance Track members continue to be eligible for the incentives.

3( e) General Guidelines  This information collection adheres to the general guidelines set forth by the Office of Management and Budget.

3( f) Confidentiality  Materials involving invasion of privacy or containing a trade secret should not be included in the Performance Track Annual Report. EPA shall treat information claimed as confidential business information ( CBI) in accordance with the requirements of 40 CFR Part 2. If the participant fails to claim the information as confidential upon submission, it may be made available to the public without further notice. EPA cannot guarantee that information submitted for reporting to EPA and claimed as confidential will be protected from release under the Freedom of Information Act ( FOIA). State participants will maintain CBI confidentiality to the extent allowed by relevant state law. Note that some state laws provide for a greater degree of access to and narrower protections for information considered confidential under federal law.

3( g) Sensitive Questions  The reporting requirements addressed in this information request do not include sensitive questions.

4. The Respondents and the Information Requested 4( a) Industry Respondents/ SIC Codes  Potential respondents include all entities regulated by EPA pursuant to its authority under the various environmental statutes that are accepted into the Performance Track program. Table 4.1 below summarizes the NAICS codes of facilities accepted into the Performance Track program during open enrollment for Rounds 1 6.

Table 4.1 PRIMARY NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM ( NAICS) CODES OF CURRENT PERFORMANCE TRACK MEMBERS Industry Group NAICS Potash, Soda, and Borate Mineral Mining 212391 Hydroelectric Power Generation 221111 Fossil Fuel Electric Power Generation 221112 Electric Bulk Power Transmission and Control 221121 Electric Power Distribution 221122 Malt Manufacturing 311213 Fruit and Vegetable Canning 311421 7 Table 4.1 PRIMARY NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM ( NAICS) CODES OF CURRENT PERFORMANCE TRACK MEMBERS Industry Group NAICS Dry, Condensed, and Evaporated Dairy Product Manufacturing 311514 Cigarette Manufacturing 312221 Carpet and Rug Mills 314110 Canvas and Related Product Mills 314912 Wood Preservation 321114 Reconstituted Wood Product Manufacturing 321219 Wood Window and Door Manufacturing 321911 Cut Stock, Re sawing Lumber, and Planing 321912 Pulp Mills 322110 Paper ( except Newsprint) Mills 322121 Paperboard Mills 322130 Nonfolding Sanitary Food Container Manufacturing 322215 Commercial Screen Printing 323113 Synthetic Organic Dye and Pigment Manufacturing 325132 All Other Basic Inorganic Chemical Manufacturing 325188 All Other Basic Organic Chemical Manufacturing 325199 Plastics Material and Resin Manufacturing 325211 Synthetic Rubber Manufacturing 325212 Noncellulosic Organic Fiber Manufacturing 325222 Medicinal and Botanical Manufacturing 325411 Pharmaceutical Preparation Manufacturing 325412 In Vitro Diagnostic Substance Manufacturing 325413 Adhesive Manufacturing 325520 Soap and Other Detergent Manufacturing 325611 Polish and Other Sanitation Good Manufacturing 325612 Surface Active Agent Manufacturing 325613 Printing Ink Manufacturing 325910 Custom Compounding of Purchased Resins 325991 All Other Miscellaneous Chemical Product and Preparation Manufacturing 325998 Unlaminated Plastics Film and Sheet ( except Packaging) Manufacturing 326113 All Other Plastics Product Manufacturing 326199 Tire Manufacturing ( except Retreading) 326211 Rubber Product Manufacturing for Mechanical Use 326291 All Other Rubber Product Manufacturing 326299 Concrete Block and Brick Manufacturing 327331 All Other Miscellaneous Nonmetallic Mineral Product Manufacturing 327999 Iron and Steel Mills 331111 Aluminum Die Casting Foundries 331521 Plate Work Manufacturing 332313 Metal Can Manufacturing 332431 Metal Coating, Engraving ( except Jewelry and Silverware), and Allied Services to Manufacturers 332812 Ball and Roller Bearing Manufacturing 332991 Other Ordnance and Accessories Manufacturing 332995 Farm Machinery and Equipment Manufacturing 333111 Printing Machinery and Equipment Manufacturing 333293 Food Product Machinery Manufacturing 333294 Office Machinery Manufacturing 333313 Optical Instrument and Lens Manufacturing 333314 Photographic and Photocopying Equipment Manufacturing 333315 Turbine and Turbine Generator Set Units Manufacturing 333611 8 Table 4.1 PRIMARY NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM ( NAICS) CODES OF CURRENT PERFORMANCE TRACK MEMBERS Industry Group NAICS Pump and Pumping Equipment Manufacturing 333911 Electronic Computer Manufacturing 334111 Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing 334220 Electron Tube Manufacturing 334411 Bare Printed Circuit Board Manufacturing 334412 Semiconductor and Related Device Manufacturing 334413 Electronic Capacitor Manufacturing 334414 Printed Circuit Assembly ( Electronic Assembly) Manufacturing 334418 Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing 334511 Automatic Environmental Control Manufacturing for Residential, Commercial, and Appliance Use 334512 Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables 334513 Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals 334515 Prerecorded Compact Disc ( except Software), Tape, and Record Reproducing 334612 Magnetic and Optical Recording Media Manufacturing 334613 Motor and Generator Manufacturing 335312 Other Communication and Energy Wire Manufacturing 335929 Current Carrying Wiring Device Manufacturing 335931 Automobile Manufacturing 336111 Motor Vehicle Body Manufacturing 336211 Truck Trailer Manufacturing 336212 Gasoline Engine and Engine Parts Manufacturing 336312 Other Motor Vehicle Electrical and Electronic Equipment Manufacturing 336322 Motor Vehicle Transmission and Power Train Parts Manufacturing 336350 Motor Vehicle Air Conditioning Manufacturing 336391 All Other Motor Vehicle Parts Manufacturing 336399 Aircraft Manufacturing 336411 Guided Missile and Space Vehicle Manufacturing 336414 Laboratory Apparatus and Furniture Manufacturing 339111 Surgical and Medical Instrument Manufacturing 339112 Surgical Appliance and Supplies Manufacturing 339113 Surgical and Appliance and Supplies Manufacturing 339113 Dental Equipment and Supplies Manufacturing 339114 Ophthalmic Goods Manufacturing 339115 Sporting and Athletic Goods Manufacturing 339920 Musical Instrument Manufacturing 339992 All Other Miscellaneous Manufacturing 339999 Heating Oil Dealers 454311 Research and Development in the Physical, Engineering, and Life Sciences 541710 Solid Waste Combustors and Incinerators 562213 Other Nonhazardous Waste Treatment and Disposal 562219 Dry Cleaning and Laundry Services ( except Coin Operated) 812320 Industrial Launderers 812332 Regulation and Administration of Transportation Programs 926120 Space Research and Technology 927110 National Security 928110 9 4( b) Information Requested from Industry Respondents ( i) Data items, including record keeping requirements  Performance Track members that are eligible for the incentives contained in the rulemaking package will need to comply with the requirements of each of the incentives. This section identifies the data items required of Performance Track facilities by rule provision. The activities required by the components of this information collection request are not customary and usual business practice.

MACT Provisions: Area sources that would need to submit MACT periodic reporting on a semi annual basis are eligible under this final rule. If such Performance Track facilities decide to avail themselves of this incentive, their periodic reporting frequency would be reduced to an annual basis. In addition, those Performance Track facilities that use pollution prevention technologies or techniques to meet MACT may submit an annual certification, instead of an annual report.

RCRA Provisions: Performance Track facilities that avail themselves of the additional accumulation time for hazardous waste provided in the rulemaking must provide prior written notification to the authorized regulatory program, and amend facility contingency plans to reflect the potential risks of additional accumulated waste. In cases where facilities wish to accumulate waste for 270 days or more, they must certify that no treatment/ disposal facility ( permitted or interim status, as defined under 40 CFR 270) exists within a 200 mile radius. Finally, such facilities are required to report on the impact of the additional accumulation time in their Performance Track Annual Report including the number of waste shipments, types of destination facilities, changes in on site and off site waste management practices occurring as a result of extended accumulation times, and information on any spills or accidents occurring at ( or from) extended accumulation units.

( ii) Industry Respondent Activities  The following are activities a respondent must perform if the respondent chooses to avail itself of a particular incentive contained in the rulemaking.

MACT Provisions:

1. Submit annual periodic report, rather than semi annual report.

2. Submit annual written certification, instead of an annual report, that the facility is meeting the emission standard by continuing to use the relevant pollution prevention technology or technique.

RCRA Provisions:

1. Submit prior written notification to the authorized regulatory program.

2. Submit amendment to contingency plan. 10 3. Report on the impact of the additional accumulation time in their Performance Track Annual Report.

4. Certify that no facility exists within a 200 mile radius in cases where waste is accumulated for up to 270 days.

4( c) State/ Local Agencies include all State and local agencies with delegated authority to administer and enforce MACT standards, and all State agencies with delegated authority to administer and enforce RCRA.

4( d) Information Requested from State/ Local Agencies ( i) Data items, including record keeping requirements  To implement the incentives contained in this rulemaking, certain State and local agencies will need to adopt revisions to their regulations, obtain approval for amended delegation authority, approve program modifications, and/ or re open and re issue permits. This section identifies the data items required of State/ local agencies by rule provision to implement these Performance Track incentives.

MACT Provisions: Depending on the delegation option chosen by a particular State/ local agency for implementing the MACT rules, such agencies may need to amend their regulations in order to implement this MACT provision. The delegation options vary in the types of changes allowed, the level of demonstration required, and the amount of time and process needed to implement them. 2 RCRA Provisions: With the exception of Hawaii, Iowa, and Puerto Rico, where EPA retains authority to administer and enforce RCRA, all other states with Performance Track member facilities will need to apply to EPA for a revision to their authorized program to implement this incentive.

( ii) State/ Local Agency Activities  The following are activities certain State and local agencies must perform in order to make the particular incentive available to Performance Track facilities located in their jurisdictions.

MACT Provisions:

1. Gain MACT delegation approval from EPA. States most frequently choose one of the following three options.

2 ICR No. 1643.04 entitled " Application Requirements for the Approval and Delegation of Federal Air Toxics Programs to State, Territorial, Local, and Tribal Agencies" addresses the variety of delegations available to State and local air authorities. 11 ( i) The " Straight Delegation" option involves rule adoption by State/ local agencies of all existing and future MACT standards unchanged from the Federal standards. Depending on the nature of this delegation option, State/ local agencies may automatically receive approval of this MACT incentive, or there may be a procedure whereby the state/ local agency requests delegation of individual standards when they are promulgated.

( ii) " Rule Adjustment" delegation option requires that State/ local agencies submit a stringency and compliance demonstration.

( iii) " Rule Substitution" delegation option requires a demonstration of the State/ local agencies' rule equivalency with the otherwise applicable Federal standard.

2. Review annual reports or annual certifications ( for facilities meeting MACT through Pollution Prevention) for Performance Track members in their jurisdiction.

RCRA Provisions:

1. States with authorized RCRA programs will need to apply to EPA to revise their authorized program to implement this incentive.

2. Review notifications of waste accumulation in excess of 90 days, and certifications that no facility exists within 200 miles for facilities that wish to accumulate hazardous waste up to 270 days.

5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities  EPA will need to continue to provide oversight of its delegated programs. Apart from the one time approval of State/ local delegated authority for the MACT and RCRA provisions, the Agency does not anticipate a significant increase in its administrative duties to implement these Performance Track incentives. For those facilities that avail themselves of the RCRA incentive, the Agency will be reviewing the Performance Track Annual Report to learn more about the impacts of the additional accumulation time. The Agency burden associated with reviewing the Performance Track Annual Report is included in the program ICR ( No. 1949.02).

The following is a list of itemized Agency activities resulting from implementation of the incentives contained in this rulemaking: 12 1. Review and approve State/ local agencies' requests to amend their MACT delegation authority.

2. Review annual MACT reports or certifications ( for facilities meeting MACT through Pollution Prevention). 3. Review and approve State agencies' requests to amend their RCRA authorization. 4. Review notifications of waste accumulation in excess of 90 days, and certifications that no facility exists within 200 miles for facilities that wish to accumulate hazardous waste up to 270 days.

5. Review amendments to facility contingency plans required of members availing themselves of the extended accumulation time incentive.

5( b) Collection Methodology and Management  Required documents and reports submitted during the period of participation for the purposes of implementation of the incentives contained in the rulemaking will be sent to an EPA Performance Track contact. The annual report will be posted on the Performance Track website. To the extent practicable, the Performance Track program will utilize electronic submissions of reporting requirements.

5( c) Small Entity Flexibility  EPA realizes that Performance Track members will vary in size. The burden to small facilities has been recognized during the development of the program and these incentives, as well as this information collection. The need to keep the program requirements flexible enough to stimulate interest in participation by small facilities was considered during the planning of the program. The incentives contained in the rulemaking do not include any elements that create any additional burden to small facilities beyond that imposed on large facilities.

5( d) Collection Schedule  With the exception of the Performance Track report that is prepared and submitted annually by respondents, the collection schedule for implementation of these incentives will depend on when Performance Track members decide to avail themselves of particular incentives.

6. Estimating the Burden and Cost of the Collection This section presents EPA's estimates of the respondent's burden hours and cost to complete the activities associated with this information collection. In using this analysis, it should be noted again that all responses to this information collection are voluntary. There are expected benefits to those who choose to participate in the Performance Track program, particularly if members avail themselves of the incentives contained in the rulemaking. EPA does not expect a response from 13 a facility where the burdens associated with preparing the response outweigh the expected benefits to the facility.

In addition to industry respondents, this section presents EPA's estimates of the State/ local agency and EPA burden hours and costs to implement the incentives associated with this rulemaking. Some State and local regulatory authorities will need to spend time and money adopting revisions to their regulations to conform with the rulemaking changes finalized today. Finally, these rulemaking changes will result in some increased administrative costs for EPA itself.

6( a) Estimating Industry Respondent Burden  This ICR requires the calculation of the amount of burden hours associated with each activity for each respondent. For those Performance Track facilities eligible for the MACT incentive contained in this rulemaking, there will be a reduction in the excess emissions reporting burden from a semi annual frequency to an annual frequency.

For Performance Track facilities availing themselves of the increase in hazardous waste accumulation time, there will be burden and costs associated with notifying the authorized regulatory program of the facility's intent to use this incentive, amending facility contingency plans, and reporting on an annual basis regarding the impact of such additional accumulation time. However, these minimal costs per facility will be more than offset by the transportation cost savings accruing to such facilities by this incentive.

6( b) Estimating Industry Respondent Costs ( i) Estimating Labor Costs  As recommended in the ICR handbook, EPA employed a graded approach in calculating cost. EPA used the Bureau of Labor Statistics' Employer Costs for Employee Compensation ( ECEC) data from June 2003 ( http:// www. bls. gov/ news. release/ ecec. t12. htm) to derive respondent labor costs. Consistent with the Office of Management and Budget's 1999 guidance Estimating Paperwork Burden ( http:// www. whitehouse. gov/ omb/ fedreg/ 5cfr1320. html), EPA used an adjusted labor rate reflective of benefits and overhead costs; this ICR employs a multiplier of 1.5 to account for both benefits and overhead. Therefore, EPA estimated the hourly cost of labor for industry respondents to be $ 72.62 for management labor, $ 62.00 for technical labor, and $ 33.44 for clerical labor. Table 6.1 provides a breakdown of labor hours and associated costs per activity. 14 Table 6.1 HOURLY LABOR RATES FOR INDUSTRY RESPONDENTS Labor Type Hourly Rate Benefits/ Overhead ( 1.5 multiplier) Adjusted Hourly Rate Management $ 48.41 $ 24.21 $ 72.62 Technical $ 41.33 $ 20.67 $ 62.00 Clerical $ 22.29 $ 11.15 $ 33.44 ( ii) Estimating Capital and Operations and Maintenance Costs  Most of the facilities applying to the Performance Track program maintain environmental compliance data as a customary business practice. EPA does not expect any start up or capital costs to affect facilities in the Performance Track program beyond those labor costs outlined in the tables in this section.

6( c) Estimating State/ Local Agency Burden and Cost  EPA used the Bureau of Labor Statistics' Employer Costs for Employee Compensation ( ECEC) data from June 2003 ( http:// www. bls. gov/ news. release/ ecec. t04. htm) to derive respondent labor costs. Consistent with the Office of Management and Budget's 1999 guidance Estimating Paperwork Burden, EPA used an adjusted labor rate reflective of benefits and overhead costs. This ICR employs a multiplier of 1.2 for overhead costs, and accounts for standard benefits by using estimates in the noted BLS data. Therefore, EPA estimated the hourly cost of labor for State/ Local Agency respondents to be $ 46.70 for management labor, $ 49.44 for technical labor, and $ 23.80 for clerical labor. Table 6.2 provides a breakdown of labor hours and associated costs for State/ local agencies.

Table 6.2 HOURLY LABOR RATES FOR STATE/ LOCAL AGENCY RESPONDENTS Labor Type Hourly Rate Benefits Overhead ( 20% Hourly) Adjusted Hourly Rate Management $ 28.42 $ 12.60 $ 5.68 $ 46.70 Technical $ 31.87 $ 11.20 $ 6.37 $ 49.44 Clerical $ 13.85 $ 7.18 $ 2.77 $ 23.80 6( d) Estimating Agency Burden and Cost  As recommended in the ICR Handbook, wage rates for EPA employees are based upon the Federal government pay scale. EPA calculated the hourly rates for EPA employees using information on annual salaries from the Internet site for the Office of Personnel Management ( http:// www. opm. gov/ oca/ 03tables/ pdf/ RUS. pdf) . EPA used the appropriate pay grade levels for management, technical, and clerical personnel. EPA divided the annual pay rate by 2080, the amount of working hours during a calendar year, to get the hourly wage rate. Consistent with the 15 Office of Management and Budget's 1999 guidance Estimating Paperwork Burden, EPA used an adjusted labor rate reflective of benefits and overhead costs. This ICR employs a multiplier of 1.4 for benefits, and a multiplier of 1.2 for overhead costs. Therefore, EPA estimated the hourly cost of Agency labor to be $ 71.55 for management labor, $ 43.28 for technical labor, and $ 21.95 for clerical labor.

Table 6.3 HOURLY LABOR RATES FOR EPA Labor Type Pay Grade Hourly Rate Benefits ( 40% Salary) Overhead ( 20% Salary) Adjusted Hourly Rate Management GS 15 $ 44.72 $ 17.89 $ 8.94 $ 71.55 Technical GS 12 $ 27.05 $ 10.82 $ 5.41 $ 43.28 Clerical GS 6 $ 13.72 $ 5.49 $ 2.74 $ 21.95 6( e) Estimating the Respondent Universe A total of 309 facilities have been accepted into the Performance Track program during the first six open enrollment periods. Of those facilities, EPA estimates that 93 facilities are likely to be eligible for the MACT incentive in today's rule. Performance Track facilities likely to be eligible for the MACT incentive include those members permitted as minor or synthetic minor air sources and in a NAICS sector likely to be subject to a MACT requirement. An analysis of EPA's IDEA database yielded 106 potential minor or synthetic minor air sources ( See http:// www. epa. gov/ compliance/ planning/ data/ multimedia/ idea/ index. html). The Agency then screened out 13 Performance Track members in sectors unlikely to be subject to MACT requirements ( i. e., nine members in the Public Facilities and Institutions sector; two members in the Mining and Construction sector; and two members in the Wholesale Retail and Shipping sector). This analysis resulted in 93 eligible facilities in the current membership. EPA estimates the annual increase in Performance Track members likely to be eligible for the MACT incentive by applying the percentage eligible among the current membership ( i. e., 30 percent) to subsequent years.

EPA estimates that 125 facilities are likely to be eligible for the RCRA incentive. 3 The number of Performance Track facilities that could potentially be affected by the RCRA portion of the rule was assembled from the list of all Performance Track facilities that identified themselves as hazardous waste generators. EPA then relied on the RCRA 2001 Hazardous Waste Data ( i. e., Biennial Reporting System) to determine the quantity of waste generated by each facility per year ( See http:// www. epa. gov/ epaoswer/ hazwaste/ data/ index. htm). The next 3 Memorandum dated December 5, 2003 from Industrial Economics, Incorporated ( IEc) to EPA's Office of Policy, Economics, and Innovation. 16 step involved excluding Performance Track facilities that are small quantity generators ( SQGs) since SQGs may already accumulate hazardous waste for up to 180 days, and thus would not benefit from today's final rule. Again, the Agency estimates the annual increase in Performance Track members likely to be eligible for the RCRA incentive by applying the percentage of the current membership to subsequent years. Table 1.1 displays EPA's projections for incentives eligibility over the ICR period.

6( f) Bottom Line Burden Hours and Cost ( i) Industry Respondent Tally  Table 6.4 presents a summary of the annual burden and costs, or cost savings, associated with each of the incentives finalized today for Performance Track facilities, and the total anticipated burden and cost savings. EPA estimates that facilities will save $ 706,846 in the aggregate over the period covered by this ICR. Table 6.4 INDUSTRY RESPONDENT BURDEN, 2004 2006 Information Collection Activity Mgr.

($ 72.62/ Hour) Tech.

($ 62.00/ Hour) Clerical ($ 33.44/ Hour) Resp.

Hours/ Year Labor Cost/ Year # Resp. Total Hours/

Year Total Cost/ Year Respondent Burden, 2004 MACT Provisions Reduced Reporting Frequency1  3.0  16.0  6.5  25.5 $ 1,427.22 116  2958.0 $ 165,557.52 2004 MACT Subtotal  3.0  16.0  6.5  25.5 $ 1,427.22 n/ a  2958.0 $ 165,557.52 2004 MACT OMB 83 I Reportable Burden 0 $ 0 RCRA Provisions Prior Written Notification to Authorized Regulatory Program of Waste Accumulation in Excess of 90 Days2 0.1 1.8 1.5 3.4 $ 169.02 156 530.4 $ 26,367.43 Amendment to Contingency Plan3 0.0 1.0 1.0 2.0 $ 95.44 156 312.0 $ 14,888.64 Impact of Additional Accumulation Time Included in Performance Track Annual Report 0.1 2.0 1.3 3.4 $ 174.73 156 530.4 $ 27,258.50 200 Mile Certification4 0.0 0.1 0.0 0.10 $ 6.20 8 0.8 $ 49.60 RCRA Costs Subtotal 0.2 4.9 3.8 8.9 $ 445.40 n/ a 1373.6 $ 68,564.18 Less Potential RCRA Transportation Cost Savings5 0.0 0.0 0.0 0.0 $ 368.98 173 0.0 $ 63,833.54 2004 RCRA Subtotal 0.2 4.9 3.8 8.9 $ 76.42 n/ a 1373.6 $ 4,730.64 2004 RCRA OMB 83 I Reportable Burden 1373.6 $ 68,564.17 2004 Burden MACT and RCRA Total  2.8  11.1  2.7  16.6 $ 1,350.80 n/ a  1584.4 $ 160,826.88 Respondent Burden, 2005 MACT Provisions Reduced Reporting Frequency  3.0  16.0  6.5  25.5 $ 1,427.22 145  3697.5 $ 206,946.90 2005 MACT Subtotal  3.0  16.0  6.5  25.5 $ 1,427.22 n/ a  3697.5 $ 206,946.90 18 Table 6.4 INDUSTRY RESPONDENT BURDEN, 2004 2006 Information Collection Activity Mgr.

($ 72.62/ Hour) Tech.

($ 62.00/ Hour) Clerical ($ 33.44/ Hour) Resp.

Hours/ Year Labor Cost/ Year # Resp. Total Hours/

Year Total Cost/ Year 2005 MACT OMB 83 I Reportable Burden 0 $ 0 RCRA Provisions Impact of Additional Accumulation Time Included in Performance Track Annual Report 0.1 2.0 1.3 3.4 $ 174.73 195 663.0 $ 34,073.13 Prior Written Notification to Authorized Regulatory Program of Waste Accumulation in Excess of 90 Days 0.1 1.8 1.5 3.4 $ 169.02 39 132.6 $ 6,591.86 Amendment to Contingency Plan 0.0 1.0 1.0 2.0 $ 95.44 39 78.0 $ 3,722.16 200 Mile Certification 0.0 0.1 0.0 0.1 $ 6.20 1 0.1 $ 6.20 RCRA Costs Subtotal 0.2 4.9 3.8 8.9 $ 445.40 n/ a 873.7 $ 44,393.35 Less Potential RCRA Transportation Cost Savings 0.0 0.0 0.0 0.0 $ 368.98 216 0.0 $ 79,699.68 2005 RCRA Subtotal 0.2 4.9 3.8 8.9 $ 76.42 n/ a 873.7 $ 35,306.33 2005 RCRA OMB 83 I Reportable Burden 873.7 $ 44,393.35 2005 Burden MACT and RCRA Total  2.8  11.1  2.7  16.6 $ 1,350.80 n/ a  2823.8 $ 242,253.23 Respondent Burden, 2006 Information Collection Activity Mgr.

($ 72.62/ Hour) Tech.

($ 62.00/ Hour) Clerical ($ 33.44/ Hour) Resp.

Hours/ Year Labor Cost/

Year # Resp. Total Hours/

Year Total Cost/

Year MACT Provisions Reduced Reporting Frequency  3.0  16.0  6.5  25.5 $ 1,427.22 182  4641.0 $ 259,754.04 2006 MACT Subtotal  3.0  16.0  6.5  25.5 $ 1,427.22 n/ a  4641.0 $ 259,754.04 2006 MACT OMB 83 I Reportable Burden 0 $ 0 RCRA Provisions 19 Table 6.4 INDUSTRY RESPONDENT BURDEN, 2004 2006 Information Collection Activity Mgr.

($ 72.62/ Hour) Tech.

($ 62.00/ Hour) Clerical ($ 33.44/ Hour) Resp.

Hours/ Year Labor Cost/ Year # Resp. Total Hours/

Year Total Cost/ Year Impact of Additional Accumulation Time Included in Performance Track Annual Report 0.1 2.0 1.3 3.4 $ 174.73 244 829.6 $ 42,635.10 Prior Written Notification to Authorized Regulatory Program of Waste Accumulation in Excess of 90 Days 0.1 1.8 1.5 3.4 $ 169.02 49 166.6 $ 8,282.08 Amendment to Contingency Plan 0.0 1.0 1.0 2.0 $ 95.44 49 98.0 $ 4,676.56 200 Mile Certification 0.0 0.1 0.0 0.1 $ 6.20 3 0.3 $ 18.60 RCRA Costs Subtotal 0.2 4.9 3.8 8.9 $ 445.40 n/ a 1094.5 $ 55,612.33 Less Potential RCRA Transportation Cost Savings 0.0 0.0 0.0 0.0 $ 368.98 270 0.0 $ 99,624.60 2006 RCRA Subtotal 0.2 4.9 3.8 8.9 $ 76.42 n/ a 1094.5 $ 44,012.27 2006 RCRA OMB 83 I Reportable Burden 1094.5 $ 55,612.33 2006 Burden MACT and RCRA Total  2.8  11.1  2.7  16.6 $ 1,350.80 n/ a  3546.5 $ 303,766.31 Total Industry Burden 2004 2006 Total 2004 2006 Burden  8.4  33.3  8.1  49.8 $ 4,052.41 n/ a  7954.7 $ 706,846.. 42 2004 2006 OMB 83 I Reportable MACT Burden 3,328.1 $ 156,724.57 2004 2006 OMB 83 I Reportable RCRA Burden 8,005.9 $ 393,622.80 Total Respondents 2004 2006 OMB 83 I Reportable Burden MACT and RCRA 3,341.8 $ 168,569.86 Total Annualized 2004 2006 OMB 83 I Reportable Burden 1,114 $ 56,190 20 Table 6.4 INDUSTRY RESPONDENT BURDEN, 2004 2006 Information Collection Activity Mgr.

($ 72.62/ Hour) Tech.

($ 62.00/ Hour) Clerical ($ 33.44/ Hour) Resp.

Hours/ Year Labor Cost/ Year # Resp. Total Hours/

Year Total Cost/ Year Notes: Shaded cells represent those figures that are reportable to OMB through the 83 I form 1 For purposes of estimating reductions in MACT reporting burden associated with annual versus semi annual reporting frequency , EPA relies on ICR No. 1984.01, Reporting and Recordkeeping Requirements for the National Emission Standards for Hazardous Air Pollutants ( NESHAP) for Plywood and Composite Wood Manufacturing Plants.

2 Prior written notification of intent to accumulate is a one time event for each facility; EPA includes annual burden and cost estimates proportional to the number of new members likely to avail themselves of the RCRA incentive each year. Thus, for 2004, EPA incorporates burden for the 156 projected eligible members who will be responsible for submitting the notification. For 2005 and 2006, EPA incorporates burden for the projected number of eligible new members in each of those years ( 39 and 49, respectively). To estimate the associated burden hours, EPA draws from ICR No. 0820.07, Hazardous Waste Generator Standards. See http:// www. epa. gov/ icr/ icrs/ 0820_ 07. html.

3 Amendments to a facility's contingency plan are a one time event for each facility; EPA includes annual burden and cost estimates proportional to the number of new members likely to avail themselves of the RCRA incentive each year ( See footnote 2 of this table for more detail on eligibility projections). To estimate the associated burden hours, EPA draws from ICR No. 0820.07, Hazardous Waste Generator Standards. See http:// www. epa. gov/ icr/ icrs/ 0820_ 07. html.

4 To estimate the burden hours required by facilities to submit the 200 mile certification, EPA reviewed burden estimates for other certifications   such major repair certifications under ICR No. 0820.07, Hazardous Waste Generator Standards   and adjusted burden downward to account for relatively diminished burden. For example, the major repair certification requires the signature of a qualified independent professional engineer, while the 200 mile certification may be conducted by qualified internal personnel. See http:// www. epa. gov/ icr/ icrs/ 0820_ 07. html. EPA includes annual burden and cost estimates proportional to the number of new members likely to require the certification annually. For example, in 2004, EPA incorporates burden for the 8 projected eligible members who will be responsible for submitting the certification. For 2005 and 2006, EPA incorporates burden for the projected number of eligible new members in each of those years ( one and three, respectively).

5 December 5, 2003 memorandum from Industrial Economics, Incorporated ( IEc) to EPA's Office of Policy, Economics, and Innovation. The analysis dis aggregates each LQG's waste streams into liquid and solid waste forms to calculate potential shipping efficiencies. Facility eligibility, in this case, is the number of eligible waste streams. Since facilities often have solid and liquid waste streams, this number exceeds the number of eligible LQGs. Consistent with the projected growth in Performance Track membership, EPA assumes a 25 percent annual growth rate for eligible waste streams ( ii) State/ Local Tally  Table 6.5 presents a summary of the annual burden hours and labor costs associated with each of the incentives finalized today for State/ local agencies, and the total anticipated burden and costs. EPA estimates that State and Local agencies will incur costs of $ 250,356 over the period covered by the ICR. 21 Table 6.5 State/ Local Agency Burden, 2004 2006 Information Collection Activity Mgr.

($ 46.70/ Hour) Tech.

($ 49.44/ Hour) Clerical ($ 23.80/ Hour) Resp. Hours/

Year Labor Cost/ Year # Resp. Total Hours/ Yr Total Cost/ Year State/ Local Agency Burden, 2004 MACT Provisions Implement Rule: Straight Delegation1 4.3 85.5 8.6 98.3 $ 4,630.25 33 3,244.7 $ 152,798.33 Implement Rule: Rule Adjustment1 3.6 72.5 7.3 83.4 $ 3,926.24 1 83.4 $ 3,926.24 Implement Rule: Rule Substitution1 11.1 221.5 22.2 254.7 $ 11,995.33 0 0.0 $ 0.00 Review Annual Periodic Reports or Review Annual Certifications ( for facilities using P2 technologies or techniques to meet MACT) 2 0.0  6.0 0.0  6.0 $ 296.64 1166  696.0 $ 34,410.24 2004 MACT Subtotal 19.0 373.5 38.0 430.4 $ 20,255.18 n/ a 2,632.1 $ 122,314.33 2004 MACT OMB 83 I Reportable Burden 3,328.1 $ 156,724.57 RCRA Provisions Request Amendment of Delegation Authority3 11.4 120.6 5.1 137.1 $ 6,617.17 347 4,662.9 $ 224,983.63 Review Notifications of Waste Accumulation in Excess of 90 Days4 0.0 0.0 0.0 0.0 $ 0.00 1478 0.0 $ 0.00 Review 200 Mile Certification5 0.0 0.1 0.0 0.1 $ 4.94 88 0.8 $ 39.55 2004 RCRA Subtotal 11.4 120.7 5.1 137.2 $ 6,622.11 n/ a 4,663.7 $ 225,023.19 2004 Total Burden MACT and RCRA 30.4 494.2 43.1 567.7 $ 26,877.29 n/ a 7,295.8 $ 347,337.52 2004 OMB 83 I Reportable Burden 7,991.8 $ 381,747.76 State/ Local Agency Burden, 2005 MACT Provisions Review Annual Periodic Reports or Review Annual Certifications ( for facilities using P2 technologies or techniques to meet MACT) 0.0  6.0 0.0  6.0 $ 296.64 145  870.0 $ 43,012.80 2005 MACT Subtotal 0.0  6.0 0.0  6.0 $ 296.64 n/ a  870.0 $ 43,012.80 22 Table 6.5 State/ Local Agency Burden, 2004 2006 Information Collection Activity Mgr.

($ 46.70/ Hour) Tech.

($ 49.44/ Hour) Clerical ($ 23.80/ Hour) Resp. Hours/

Year Labor Cost/ Year # Resp. Total Hours/ Yr Total Cost/ Year 2005 MACT OMB 83 I Reportable Burden 0 $ 0 RCRA Provisions Review Notifications of Waste Accumulation in Excess of 90 Days 0.0 0.0 0.0 0.0 $ 0.00 37 0.0 $ 0.00 Review 200 Mile Certification 0.0 0.1 0.0 0.1 $ 4.94 1 0.1 $ 4.94 2005 RCRA Subtotal 0.0 0.1 0.0 0.1 $ 4.94 n/ a 0.1 $ 4.94 2005 Total Burden MACT and RCRA 0.0  5.9 0.0  5.9 $ 291.70 n/ a  869.9 $ 43,007.86 2005 OMB 83 I Reportable Burden .1 $ 4.94 State/ Local Agency Burden, 2006 MACT Provisions Review Annual Periodic Reports or Review Annual Certifications ( for facilities using P2 technologies or techniques to meet MACT) 0.0  6.0 0.0  6.0 $ 296.64 182  1092.0 $ 53,988.48 2006 MACT Subtotal 0.0  6.0 0.0  6.0 $ 296.64 n/ a  1092.0 $ 53,988.48 2006 MACT OMB 83 I Reportable Burden 0 $ 0 RCRA Provisions Review Notifications of Waste Accumulation in Excess of 90 Days 0.0 0.0 0.0 0.0 $ 0.00 46 0.0 $ 0.0 Review 200 Mile Certification 0.0 0.1 0.0 0.1 $ 4.94 3 0.3 $ 14.83 2006 RCRA Subtotal 0.0 0.1 0.0 0.1 $ 4.94 n/ a 0.3 $ 14.83 2006 Total Burden MACT and RCRA 0.0  5.9 0.0  5.9 $ 291.70 n/ a  1091.7 $ 53,973.65 2006 OMB 83 I Reportable Burden .3 $ 14.83 Total 2004 2006 Burden MACT and RCRA 30.4 482.4 43.1 555.9 $ 26,293.90 n/ a 5334.2 $ 250,356.01 Total 2004  2006 OMB 83 I Reportable Burden 7992.2 $ 381,767.53 23 Table 6.5 State/ Local Agency Burden, 2004 2006 Information Collection Activity Mgr.

($ 46.70/ Hour) Tech.

($ 49.44/ Hour) Clerical ($ 23.80/ Hour) Resp. Hours/

Year Labor Cost/ Year # Resp. Total Hours/ Yr Total Cost/ Year Annualized OMB 83 I Reportable Burden 2664 127,255.84 ( iii) Agency Tally  Table 6.6 presents a summary of the annual burden hours and labor costs associated with each of the incentives finalized today for the Agency, and the total anticipated burden and costs. EPA estimates that the Agency will incur costs of $ 258,815 over the period covered by the ICR.

Table 6.6 EPA Burden, 2004 2006 Information Collection Activity Mgr.

($ 71.55/ Hour) Tech.

($ 43.28/ Hour) Clerical ($ 21.95/

Hour) Resp. Hours/

Year Labor Cost/ Year # Resp. Total Hours/

Year Total Cost/ Year EPA Burden, 2004 MACT Provisions Review and Approve Straight Delegation1 3.3 65.0 6.5 74.8 $ 3,188.41 33 2466.8 $ 105,217.61 Review and Approve Rule Adjustment1 3.0 60.0 6.0 69.0 $ 2,943.15 1 69.0 $ 2,943.15 Review and Approve Rule Substitution11 8.5 170.0 17.0 195.5 $ 8,338.93 0 0.0 $ 0.00 Review Annual Periodic Reports or Review Annual Certifications ( for facilities using P2 technologies or techniques to meet MACT) 2 0.0  6.0 0.0  6.0 $ 259.68 07 0.0 $ 0.00 2004 MACT Subtotal 14.8 289.0 29.5 333.3 $ 14,210.81 n/ a 2535.8 $ 108,160.76 RCRA Provisions Approve Amendment of Delegation Authority3 9.7 81.4 2.6 93.7 $ 4,275.73 348 3186.3 $ 145,374.77 24 Table 6.6 EPA Burden, 2004 2006 Information Collection Activity Mgr.

($ 71.55/ Hour) Tech.

($ 43.28/ Hour) Clerical ($ 21.95/

Hour) Resp. Hours/

Year Labor Cost/ Year # Resp. Total Hours/

Year Total Cost/ Year Review Notifications of Waste Accumulation in Excess of 90 Days4 0.0 0.0 0.0 0.0 $ 0.00 99 0.0 $ 0.00 Review 200 Mile Certification5 0.0 0.1 0.0 0.1 $ 4.33 09 0.0 $ 0.00 Review Contingency Plan Amendment6 0.0 0.5 0 0.5 $ 21.64 156 78.0 $ 3,375.84 2004 RCRA Subtotal 9.7 82.0 2.6 94.3 $ 4,301.70 n/ a 3264.3 $ 148,750.61 2004 Total Burden 24.5 371.0 32.1 427.6 $ 18,512.50 n/ a 5800.0 $ 256,911.37 EPA Burden, 2005 MACT Provisions Review Annual Periodic Reports or Review Annual Certifications ( for facilities using P2 technologies or techniques to meet MACT) 0.0  6.0 0.0  6.0 $ 259.68 0 0.0 $ 0.00 2005 MACT Subtotal 0.0  6.0 0.0  6.0 $ 259.68 n/ a 0.0 $ 0.00 RCRA Provisions Review Notifications of Waste Accumulation in Excess of 90 Days 0.0 00 0.0 00 $ 0.00 2 0.0 $ 0.00 Review 200 Mile Certification 0.0 0.1 0.0 0.1 $ 4.33 0 0.0 $ 0.00 Review Contingency Plan Amendment 0.0 0.5 0.0 0.5 $ 21.64 39 19.5 $ 843.96 2005 RCRA Subtotal 0.0 0.6 0.0 0.6 $ 25.97 n/ a 19.5 $ 843.96 2005 Total Burden 0.0  5.4 0.0  5.4  233.71 n/ a 19.5 $ 843.96 EPA Burden, 2006 MACT Provisions Review Annual Periodic Reports or Review Annual Certifications ( for facilities using P2 technologies or techniques to meet MACT) 0.0  6.0 0.0  6.0 $ 259.68 0 0.0 $ 0.00 25 Table 6.6 EPA Burden, 2004 2006 Information Collection Activity Mgr.

($ 71.55/ Hour) Tech.

($ 43.28/ Hour) Clerical ($ 21.95/

Hour) Resp. Hours/

Year Labor Cost/ Year # Resp. Total Hours/

Year Total Cost/ Year 2006 MACT Subtotal 0.0  6.0 0.0  6.0 $ 259.68 n/ a 0.0 $ 0.00 RCRA Provisions Review Notifications of Waste Accumulation in Excess of 90 Days 0.0 0.0 0.0 0.0 $ 0.00 3 0.00 $ 0.00 Review 200 Mile Certification 0.0 0.1 0.0 0.1 $ 4.33 0 0.0 $ 0.00 Review Contingency Plan Amendment 0.0 0.5 0 0.5 $ 21.64 49 24.5 $ 1,060.36 2006 RCRA Subtotal 0.0 0.6 0.0 0.6 $ 25.97 n/ a 24.5 $ 1,060.36 2006 Total Burden 0.0  5.4 0.0  5.4 $ 233.71 n/ a 24.5 $ 1,060.36 Total 2004 2006 Burden 24.5 360.2 32.1 416.8 $ 18,045.08 n/ a 5844.0 $ 258,815.69 26 Table 6.6 EPA Burden, 2004 2006 Information Collection Activity Mgr.

($ 71.55/ Hour) Tech.

($ 43.28/ Hour) Clerical ($ 21.95/

Hour) Resp. Hours/

Year Labor Cost/ Year # Resp. Total Hours/

Year Total Cost/ Year Notes:

1 Delegation options are a one time event and therefore are only included in the ICR burden and cost during the first year of the ICR. MACT delegation calculations draw upon ICR No.

1643.04, Application Requirements for the Approval and Delegation of Federal Air Toxics Programs ( Table 3b), which estimates the delegation options chosen by states. EPA applies the proportions for straight delegation, rule adjustment, and rule substitution to derive the number of states likely to choose each delegation option. Table 1 of ICR No. 1643.04 lists technical hours required for each delegation option, and calculates managerial and clerical hours at 5 and 10 percent of the technical hours, respectively. See http:// www. epa. gov/ icr/ icrs/ 1643_ 04. html.

2 EPA references ICR No. 1871.02, National Emission Standards for Hazardous Air Pollutants: Generic Maximum Achievable Control Technology, and allocates 100 percent of the reduction in hours to technical labor. See http:// www. epa. gov/ icr/ icrs/ 1871_ 02. html.

3 Delegation options are a one time event and therefore are only included in the ICR burden and cost during the first year of the ICR. EPA relies on ICR No. 0969.05, Final Authorization for Hazardous Waste Management Programs, to determine the burden hours associated with revisions to RCRA program delegation. There have been an average of seven rules per year included in the State Program Advisories sent by EPA to all delegated programs over the past seven years. This ICR assumes that the Performance Track rulemaking will account for approximately one seventh of the total burden hours estimated in ICR No. 0969.05. See http:// www. epa. gov/ icr/ icrs/ 0969_ 05. html.

4 EPA estimates that the review of Prior Notifications of Intent to Accumulate Waste will require a nominal amount of time. Prior notifications are a one time event for each facility, and EPA includes them in annual burden and cost estimates proportional to the number of new members likely to avail themselves of the RCRA incentive each year. Thus, for 2004, EPA incorporates burden for the 156 projected eligible members who will be responsible for submitting the notification. For 2005 and 2006, EPA incorporates burden for the projected number of eligible new members in each of those years ( 39 and 49, respectively). To estimate the associated burden hours, EPA draws from ICR No. 0820.07, Hazardous Waste Generator Standards.

See http:// www. epa. gov/ icr/ icrs/ 0820_ 07. html.

5 To estimate the burden hours required by the Agency to process the 200 mile certification, EPA reviewed burden estimates for other certifications   such major repair certifications under ICR No. 0820.07, Hazardous Waste Generator Standards   and adjusted burden downward to account for relatively diminished burden. For example, the major repair certification is certified by a professional engineer,

and poor repair design may result in direct releases to the environment. The 200 mile certification is less complex and will require less review time on the part of the Agency. EPA includes annual burden and cost estimates proportional to the number of new members likely to require the certification each year. For example, in 2004, EPA incorporates burden for the 8 projected eligible members who will be responsible for submitting the certification. For 2005 and 2006, EPA incorporates burden for the projected number of eligible new members in each of those years ( one and three, respectively). See http:// www. epa. gov/ icr/ icrs/ 0820_ 07. html.

6 To estimate the Agency burden required to process amendments to facilities' contingency plans, EPA relies on ICR No. 0820.07, Hazardous Waste Generator Standards. This ICR attributes all burden hours to EPA ( and none to states); EPA includes annual burden and cost estimates proportional to the number of new members likely to require amendments in each of those years ( See footnote 4 of this table for more detail on eligibility projections). See http:// www. epa. gov/ icr/ icrs/ 0820_ 07. html.

7 For the purposes of this ICR, EPA assumes that states are the permitting authorities for MACT delegation. Therefore, the Agency attributes all burden and cost savings to states for reductions in the frequency of reviewing annual periodic reports or annual certifications.

8 To estimate the number of states that may need to request an amendment to their delegation authority, EPA uses the number of RCRA authorized states with one or more Performance Track facilities currently eligible for this incentive.

9 For reviews of facility notifications of waste accumulation in excess of 90 days, as well as reviews of 200 mile certifications, EPA attributes cost and burden proportional to the number of RCRA authorized states approved to review such notifications for their Performance Track facilities. See footnote 8 of table 6.5 for more detail. 27 ( iv) Variations in the Annual Bottom Line  EPA anticipates significant variation ( greater than 25 percent) in the annual respondent reporting burden over the course of the requested ICR period. Facilities, State/ Local Agencies, and the Agency itself must incur several first year costs ( e. g., as related to MACT delegation) to lay the groundwork for the cost and burden savings realized in ICR years two and three.

6( g) Reasons for Change in Burden  The incentives included in today's final rulemaking were not developed at the time the initial ICR for the Performance Track program was submitted to OMB.

6( h) Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 3,778 hours per year at an average of 277 facilities per year. The average annual public reporting and recordkeeping burden is 13.6 hours per facility. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

EPA projects that this rulemaking will yield an aggregate savings of $ 197,674 across industry, State and Local agencies, and EPA over the three year period covered by this ICR. The cost and burden hour savings of the MACT incentives are diminished in part by the RCRArelated cost and burden increases to State/ Local agencies and EPA. Performance Track members, however, receive net benefits for each incentive, and overall rulemaking benefits of $ 706,846 over the ICR period. Table 6.7 below displays aggregate burden calculations for 2004 2006.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OA 2004 0001 which is available for public viewing at the Office of Administrator Docket at http:// www. epa. gov/ edocket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Office of Environmental Information Docket ( Where Office of Administrator documents are held) is ( 202) 566 1752. An electronic version of the public docket 28 is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. OA 2004 0001 and OMB control number 2010 0032 in any correspondence.

Table 6.7 Aggregate Burden, 2004 2006 Information Collection Activity Managerial Technical Clerical Resp. Hours Labor Cost Total Hours Total Cost MACT Provisions Industry  9.0  48.0  19.5  76.5 $ 4,281.66  11,296.5 $ 632,258.46 States 19.0 361.5 38.0 418.4 $ 19,661.90 670.1 $ 25,313.05 Agency 14.8 277.0 29.5 321.3 $ 13,691.45 2535.8 $ 108,160.76 MACT Subtotal 24.7 590.5 48.0 663.2 $ 29,071.69  8090.7 $ 498,784.65 RCRA Provisions Industry 0.6 14.7 11.4 26.7 $ 229.25 3341.8 $ 74,587.96 States 11.4 120.9 5.1 137.4 $ 6,632.00 4664.1 $ 225,042.96 Agency 9.7 83.2 2.6 95.5 $ 4,353.63 3308.3 $ 150,654.93 RCRA Subtotal 21.7 218.8 19.1 259.7 $ 11,214.88 11,314.1 $ 301,109.93 Full Rulemaking ( MACT and RCRA) Industry  8.4  33.3  8.1  49.8 $ 4,052.41  7954.7 $ 706,846.42 States 30.4 482.4 43.1 555.9 $ 26,293.90 5334.2 $ 250,356.01 Agency 24.5 360.2 32.1 416.8 $ 18,045.08 5844.0 $ 258,815.69 Total Burden 46.5 809.3 62.1 922.8 $ 40,286.57 3223.5 $ 197,674.72 29 Table 6.8 Summary OMB 83 I Reportable ( Only Positive) Aggregate Burden, 2004 2006 Information Collection Activity Total Hours Total Cost 2004 Respondents MACT 0 $ 0 RCRA 1,373.6 $ 68,574.16 States MACT 3,328.1 $ 156,724.57 RCRA 4,663.7 $ 225,023.18 2005 Respondents MACT 0 $ 0 RCRA 873.7 $ 44,393.35 States MACT 0 $ 0 RCRA 0.1 $ 4.94 2006 Respondents MACT 0 $ 0 RCRA 1,094.5 $ 55,612.34 States MACT 0 $ 0 RCRA 0.3 $ 14.83 Respondent Burden 2004 2006 Subtotal 3,341.8 $ 168,579.85 State Burden 2004 2006 Subtotal 7,992.2 $ 381,767.52 MACT 2004 2006 Subtotal 3,328.1 $ 156,724.57 RCRA 2004 2006 Subtotal 8,005.9 $ 393,622.8 Total Reportable Burden 2004 2006 11,334 $ 550,347.37 Total Annualized Burden 2004 2006 3,778 $ 183,449.12


[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36541-36542]
[FR Doc No: 2011-15592]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0110]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Prescription Drug Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Prescription Drug Advertisements''
has been approved by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of January 24, 2011
(76 FR 4117), the Agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0686.
The approval expires on June 30, 2014. A

copy of the supporting statement for this information collection is
available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: June 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15592 Filed 6-21-11; 8:45 am]
BILLING CODE 4160-01-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460

                                                	OFFICE OF CHEMICAL SAFETY AND
                                                           POLLUTION PREVENTION

MEMORANDUM

Date: 	November 27, 2012

SUBJECT:	Trifloxystrobin: Review of Human Incidents

PC Code: 129112
DP Barcode: D407067
Decision No.: 469960
Registration No.: NA
Petition No.: NA
Regulatory Action: NA
Risk Assessment Type: NA
Case No.: NA
TXR No.: NA
CAS No.: 141517-21-7
MRID No.: NA
40 CFR: NA
		              									Ver.Apr.08

FROM:	Shanna Recore, Industrial Hygienist
		Toxicology and Epidemiology Branch
		Health Effect Division (7509P)
			and
		Elizabeth Evans, Environmental Protection Specialist
		Toxicology and Epidemiology Branch
		Health Effect Division (7509P)

THROUGH:	David Miller, Acting Branch Chief
		Toxicology and Epidemiology Branch
		Health Effects Division (7509P)

TO: 		Nancy Tsaur, Risk Assessor
		Risk Assessment Branch III
		Health Effects Division (7509P)
			and
		Moana Appleyard, Chemical Review Manager
		Risk Management & Implementation Branch V
		Pesticide Re-evaluation Division (7508P)

Summary and Conclusions

Based on the low frequency and severity of incident cases reported for trifloxystrobin in both IDS and NIOSH SENSOR, there does not appear to be a concern at this time that would warrant further investigation.  The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.

Detailed Review

   I. ACTION REQUESTED

This review is intended to fulfill our requirement to docket summaries of incident data that were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part of the problem formulation phase of registration review. Reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., an "incident") are largely self-reported and therefore, generally speaking, neither exposure to a pesticide or reported symptom (or the connection between the two) is validated or otherwise confirmed.  Typically, causation cannot be determined based on incident data.  However, incident information can be an important source of feedback to the Agency:  incidents of severe outcome, or a suggested pattern or trend among less severe incidents, can signal the Agency to further investigate a particular chemical or product. Observational epidemiology studies relate the risk of disease, e.g., cancer, and exposure to an agent such as a pesticide product in the general population or specific sub-groups like pesticide applicators.

   II. BACKGROUND

Trifloxystrobin is a strobilurin-class fungicide that controls foliar fungal diseases and soilborne/seedling fungal diseases. It works by interrupting mitochondrial respiration in plant-pathogenic fungi, thus inhibiting spore germination and mycelial growth. It is a broad-spectrum preventative fungicide used for control of many plant diseases in various fruit, nut, vegetable, and field crops, including corn and soybean.

For this evaluation, both OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient trifloxystrobin (PC Code 129112).  The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to trifloxystrobin exposure.

In addition, findings from the AHS were reviewed.  The Agricultural Health Study (AHS) is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer.  Trifloxystrobin is not included in the AHS, and therefore this study does not provide information for this report.

   III. RESULTS/DISCUSSION
         a. IDS (Incident Data System)

OPP's IDS includes reports of alleged human health incidents from various sources, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants, other federal and state health and environmental agencies, and individual consumers. Since 1992, OPP has compiled these reports in IDS.  IDS contains reports from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report.

IDS records incidents in one of two modules: Main IDS and Aggregate IDS:

         o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specific.  This system stores incident data for death, major and moderate incidents, and it includes information about the location, date and nature of the incident.  Main IDS incidents involving only one pesticide are considered to provide more certain information about the potential effects of exposure from the pesticide.

         o Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes). These are reported by registrants only as counts in what are aggregate summaries.

For the Main IDS, from January 1, 2007 to September 13, 2012, there was 1 incidents reported for single chemical only in the database and 10 additional incidents reported involving more than one chemical. These incidents were classified as moderate severity.  In the single chemical incident, an adult male became ill after blowing into a hose to clear the product causing the product to blow into his face. He went to the emergency room and was admitted. No further information is available (Table 1).

In Aggregate IDS, from January 1, 2007 to September 13, 2012, there were 20 reported incidents involving trifloxystrobin.

         b. NIOSH SENSOR

The NIOSH-led SENSOR-Pesticides database covers 11 states from 1998-2008, although reporting varies from state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, state Department of Labor workers' compensation claims when reported by physicians, reports from State Departments of Agriculture, and physician reports to state Departments of Health. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is of particular value in providing that information. A state SENSOR contact specialist attempts to follow-up with cases and obtains medical records to verify symptoms, circumstances surrounding the exposure, severity, and outcome.  Using standardized protocol and case definitions derived from poison center reporting, SENSOR-Pesticides coordinators at State Departments of Health enter the incident interview description provided by the case, medical report, physician into the data system. In order to be included in the database, all SENSOR-Pesticides cases, including low severity cases, must have at least two adverse health effects.

In SENSOR-Pesticides from 1998 to 2008, 11 cases, stemming from 10 exposure events, involving trifloxystrobin were identified.    Two cases were exposed to a single active ingredient whereas the other 9 involve exposure to multiple active ingredients.  Two cases are moderate in severity and 9 cases are low severity.

Of the 11 cases, six reported respiratory symptoms, four reported dermal symptoms, four reported gastrointestinal symptoms, and three reported ocular symptoms.  It is noted that two of reported ocular symptoms despite wearing the label-required eye protection; however, both of these cases involved the application of multiple active ingredients.  One case narrative states "Patient was spraying on hop field, wearing full protection: half face respirator, rubber boots, rubber gloves, raingear and goggles.  But next day around 11:00 am he experienced ocular symptoms.  He doesn't know how he got exposed."  The second case narrative states "A 33 y/o male developed ocular symptoms after applying pesticides and fertilizers in a tank mix.  He was wearing eye protection."  Both cases were classified as low severity.

Eight of the 11 cases are coded as "work-related".  Of these, seven cases resulted from occupational pesticide exposure.  Specifically, five of these cases are pesticide applicator exposures, one involved a farmworker thinning apples, and one case was coded "work-related" but no further detail provided.

One of the two moderate severity cases involved a single active ingredient.  This case occurred in California in 2008 and involved application of Flint Fungicide (EPA reg #<PHONE_NUMBER>7).  This case was spraying Flint Fungicide from a tractor, reported wearing all required PPE, but he blew into a hose to clear it, and the product contacted him. He experienced gastrointestinal symptoms and was hospitalized for one day and reported missing at least one day of work.  The second moderate severity case occurred in Washington in 2005 and involved a 33 year old male applicator who went to a clinic complaining of neurological and gastrointestinal symptoms after applying Flint Fungicide.  This case, however, was applying Axinphosmethyl 50W in addition to Flint Fungicide.

         c. AHS

The AHS is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. If there are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem formulation/scoping phase of the process and, if appropriate, fully reviewed in the risk assessment phase of the process. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture.

Trifloxystrobin is not included in the AHS, and therefore this study does not provide information for this report.

   IV. CONCLUSION

Based on the low frequency and severity of incident cases reported for trifloxystrobin in both IDS and NIOSH SENSOR, there does not appear to be a concern at this time that would warrant further investigation.  The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.

Table 1. Main IDS Incident involving Trifloxystrobin as a single chemical
Human Incident
Chemical: Trifloxystrobin
PC Code: 129112

Incident Package Report
Incident Date
Location
Country
Reg Number
Product Name
Exposure Severity Codes
Incident Description
020180 - 00059
                                                                      5/24/2008
CA
US
000264-00777
FLINT FUNGICIDE
HC
An adult male became ill after blowing into a hose to clear the product causing the product to blow into his face. He went to ER and was admitted.
*HC-Human Moderate (if the person alleged or exhibited symptoms more pronounced, more prolonged or of a more systemic nature than minor symptoms; and involved some form of treatment, even though symptoms were not life threatening and the person returned to his/her pre-exposure state of health with no additional residual disability)