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-------------------------------------------------------------------------------- INFORMATION COLLECTION REQUEST FOR -------------------------------------------------------------------------------- REPORTING REQUIREMENTS FOR BEACH ACT GRANTS (RENEWAL)                                                                                EPA ICR No. 2048.04                            OMB Control No. 2040-0244

                                 January 2012                                                                                Contents 1.	Identification of the Information Collection	1 1(a)	Title of the Information Collection	1 1(b)	Short Characterization/Abstract	1 2.	Need for and Use of the Collection	2 2(a)	Need/Authority for the Collection	2 2(b)	Practical Utility/Users of the Data	2 3.	Nonduplication, Consultations, and Other Collection Criteria	2 3(a)	Nonduplication	2 3(b)	Public Notice Required Prior to ICR Submission to OMB	2 3(c)	Consultations	3 3(d)	Effects of Less Frequent Collection	3 3(e)	General Guidelines	3 3(f)	Confidentiality	3 3(g)	Sensitive Questions	3 4.	The Respondents and the Information Requested	3 4(a)	Respondents/SIC Codes	3 4(b)	Information Requested	3 5.	The Information Collected-Agency Activities, Collection Methodology, and Information Management	6 5(a)	Agency Activities	6 5(b)	Collection Methodology and Management	6 5(c)	Small Entity Flexibility	7 5(d)	Collection Schedule	7 6.	Estimating the Burden and Cost of the Collection	7 6(a)	Estimating Respondent Burden	7 6(b)	Estimating Respondent Cost	8 6(c)	Estimating Agency Burden and Cost	12 6(d)	Estimating the Respondent Universe and Total Burden and Costs	13 6(e)	Bottom Line Burden Hours and Cost Tables	13 6(f)	Reasons for Change in Burden	14 6(g)	Burden Statement	15

Tables Table 1. BEACH Act Grant performance criteria summary	4 Table 2. Individual respondent 3-year state burden hours	9 Table 3. Total Agency burden hours per activity over 3 years	13 Table 4. Annualized respondent burden and cost	13 Table 5. Total annualized respondent and Agency burden and costs	14 Table 6. Change in annual state burden for performance criteria tasks	14

Information Collection Request 1.	Identification of the Information Collection 1(a)	Title of the Information Collection  BEACH Act Grant Program 1(b)	Short Characterization/Abstract  The Beaches Environmental Assessment and Coastal Health (BEACH) Act amends the Clean Water Act (CWA) in part and authorizes the U.S. Environmental Protection Agency (EPA) to award BEACH Act Program Development and Implementation Grants to coastal and Great Lakes states, tribes, and territories (collectively referred to as states) for their beach monitoring and notification programs. The grants will assist those states to develop and implement a consistent approach to monitor recreational water quality; assess, manage, and communicate health risks from waterborne microbial contamination; notify the public of pollution occurrences, and post beach advisories and closures to prevent public exposure to microbial pathogens. To qualify for a BEACH Act Grant, a state must submit information to EPA documenting that its beach monitoring and notification program is consistent with nine performance criteria outlined in the National Beach Guidance and Performance Criteria for Recreation Waters. For EPA to award a BEACH Act Implementation Grant, a state must document that its coastal monitoring and notification program includes or will include the following: Risk-based beach evaluation and classification.  Sampling design and monitoring implementation plan.  Monitoring report submission and delegation.  Methods and assessment procedures.  Public notification and risk communication plan.  Measures to notify EPA and local governments.  Measures to notify the public.  Notification report submission and delegation. Public evaluation of program. All beach program information will be collected by EPA's Office of Science and Technology, stored in the Beach Database, and displayed on EPA's Beaches website for use by the public, state environmental and public health agencies, and EPA. The third Information Collection Request (ICR) approval period expires in January 2012. This Supporting Statement is for the renewal ICR being submitted to Office of Management and Budget (OMB) for re-approval of the Reporting Requirements for BEACH Act Grants information collection. For the fourth ICR approval period after rule promulgation, EPA estimates that the annual respondent burden for the 37 eligible coastal and Great Lakes states, tribes, and territories will be 88,812 hours and operations and maintenance (O&M) costs of $3,943,080, for a total annual cost of $8,571,118. There are no start-up costs. Because the Agency does not incur any additional O&M costs, the total annual respondent and Agency burden and cost estimate is 91,957 hours (respondents and Agency) and $8,778,500 (which includes the respondent and Agency burden costs and the respondent O&M costs of $3,943,080). EPA requests that OMB review and approve this ICR package proposal for 3 years. 2.	Need for and Use of the Collection 2(a)	Need/Authority for the Collection  The BEACH Act (Public Law 106-284) established a grant program to assist states in implementing a uniform monitoring and notification program for their coastal recreational waters. As a condition of receipt of a BEACH Act Grant, states must show evidence of meeting the nine performance criteria and the conditions under the BEACH Act. Therefore, a state applying for a grant must submit information on its programs to its EPA Regional Coordinator to document that its program is consistent with the performance criteria. 2(b)	Practical Utility/Users of the Data  Data will be used by EPA, state and local environmental and public health agencies, and the public. EPA will use the information submitted by a state to determine whether the state's program is consistent with the performance criteria and the BEACH Act. State and local environmental and public health agencies will use the data as an indicator of program performance, and the public will use the data as reference to make informed decisions before going to the beach. The information provided by each state will also be used to report the status of beach monitoring and notification programs nationwide. A state must implement measures to notify EPA of the results of its water quality sampling. Therefore, these data will be used to create and maintain a national database of water quality trends, advisories, and closings. 3.	Nonduplication, Consultations, and Other Collection Criteria 3(a)	Nonduplication The information requested from the states is required for receipt of a BEACH Act Grant and is not available from other sources. EPA has made every reasonable attempt to ensure that the beach monitoring and notification data and information requested through the BEACH Act Grant Program is not already available through less burdensome mechanisms. 3(b)	Public Notice Required Prior to ICR Submission to OMB EPA published the first Federal Register notice for this ICR on September 20, 2011 (76 FR 58266). EPA requested comment from the public. EPA received one comment during the comment period, which was not relevant to the information collection. 3(c)	Consultations  EPA consulted with the following state beach coordinators, asking them to compare EPA's average burden estimates with their experience: Shannon Briggs (Michigan), Jon Dinneen (Connecticut), and Heather Merritt (Maryland). Shannon commented that the numbers were similar to Michigan's estimates and were therefore reasonable.  Jon provided a detailed breakdown of Connecticut's burden on a task-by-task basis, with estimates that were higher in some places and lower in others, resulting in an overall annual burden higher than EPA's estimates by 476 hours. Heather responded that the burden estimates seemed reasonable overall, but noted that Maryland spends more time on sample collection. Based on these responses, EPA feels that the state burden provided in the ICR is a reasonable estimate for an average state. 3(d)	Effects of Less Frequent Collection The requirement for a state to submit its monitoring and notification data is a statutory requirement under the BEACH Act. The frequency and format of such submittal is at the Administrator's discretion [see CWA section 406(b)(B)(3)]. Since 2003, EPA has required states to submit their monitoring and notification data annually. However, to provide more up-to-date information to the public on the state of their beaches, the Agency is encouraging more frequent reporting. The Agency continues to expect state grant performance reports annually. 3(e)	General Guidelines  The BEACH Act Grant Program will be conducted in accordance with the Paperwork Reduction Act [Title 5 of the Code of Federal Regulations (CFR) section 1320.5(d)(2)] and will adhere to OMB's general guidelines for information collections. 3(f)	Confidentiality  Measures to ensure the confidentiality of the collected beach monitoring and notification data are not necessary because the information submitted by the respondents is public information. 3(g)	Sensitive Questions  No information of sensitive nature will be collected as a result of this ICR. 4.	The Respondents and the Information Requested 4(a)	Respondents/SIC Codes  Information collected by EPA under the BEACH Act will be submitted by environmental and public health agencies in coastal and Great Lakes states, territories, and tribes. No private industries will be required to submit information, and, therefore, no SIC codes are relevant. 4(b)	Information Requested  EPA is requiring states to provide information on how a beach monitoring and notification program is consistent with the following nine performance criteria, developed from the BEACH Act and summarized in Table 1.   Table 1. BEACH Act Grant performance criteria summary Category Performance criteria Requirement BEACH Act section Evaluation and Classification                                        1 Risk-based Beach Evaluation and Classification 406(b)(2)(A)(ii-iv) 406(c)(1) Monitoring                                        2 Sampling Design and Monitoring Implementation Plan 406(c)(3)

                                       3 Monitoring Report Submission and Delegation 406(b)(3)(A), (B) 406(c)(2)

                                       4 Methods and Assessment Procedures 406(c)(4) Public Notification and Prompt Risk Communication                                        5 Public Notification and Risk Communication Plan 406(c)(7)

                                       6 Measures to Notify EPA and Local Governments 406(c)(5)

                                       7 Measures to Notify the Public 406(c)(6)

                                       8 Notification Report Submission and Delegation 406(b)(3)(A), (B) 406(c)(2) Public Evaluation                                        9 Public Evaluation of Program 406(b)(2)(A)(v)

Risk-based Beach Evaluation and Classification A state must develop a risk-based beach evaluation and classification plan and apply it to state coastal recreation waters. A state or tribal program must describe the factors used in its evaluation and classification process and explain how its beaches are ranked as a result of the process. The process must result in the identification of a list of coastal recreation waters in the state, including coastal recreation waters adjacent to beaches or similar points of access used by the public. Sampling Design and Monitoring Plan A state must develop a sampling design and monitoring implementation plan. The plan must adequately address the frequency and location of monitoring and assessment of coastal recreation waters according to the periods of recreational use of the waters, the nature and extent of use during certain periods, the proximity of the waters to known point sources and nonpoint sources of pollution, and any effect of storm events on the waters. Monitoring Report Submission and Delegation A state must develop a mechanism to collect relevant information, submit timely reports to EPA, and document any delegation of monitoring responsibilities to local governments. Report Submission A state recipient of a grant must submit to the EPA Administrator timely information and reports that describe the data collected as part of the monitoring program and the actions taken to notify the public when water quality standards are exceeded. Delegation If monitoring responsibilities are delegated to local governments, the state grant recipient must describe the process by which the state may delegate to local governments responsibility for implementing the monitoring program. Methods and Assessment Procedures A state must develop detailed methods and assessment procedures. Those procedures must adequately address both the methods to be used for detecting levels of pathogens and pathogen indicators that are harmful to human health and the assessment procedures for identifying short-term increases in pathogens and pathogen indicators that are harmful to human health. Public Notification and Risk Communication Plan A state must develop an overall public notification and risk communication plan. The plan must describe the state's public notification efforts and measures to inform the public of the potential risks associated with water contact activities in the coastal recreation waters that do not meet applicable water quality standards. Measures to Notify EPA and Local Governments A state must identify measures for promptly communicating to EPA and local governments of the occurrence, nature, location, pollutants involved, and extent of any exceeding of, or likelihood of exceeding, applicable water quality standards for pathogens and pathogen indicators. The state must identify how that information will be promptly communicated to EPA and to a designated official of the local government that has jurisdiction over land adjoining the coastal recreation waters for which the failure to meet applicable standards has been identified. Measures to Notify the Public A state must develop measures to notify the public by posting signs at beaches or similar points of access or through functionally equivalent communication measures that are sufficient to give notice to the public that the coastal recreation waters are not meeting or are not expected to meet applicable water quality standards for pathogens and pathogen indicators. Notification Report Submission and Delegations A state must develop a mechanism to collect relevant information, submit timely reports to EPA, and document any delegation of notification responsibilities to local governments. Report Submission A state or tribal recipient of a grant must submit to the EPA Administrator timely information and reports that describe data collected as part of the notification program and the actions taken to notify the public when water quality standards are exceeded. Delegation If notification responsibilities are delegated to local governments, the state grant recipient must describe the process by which the state may delegate to local governments responsibility for implementing the notification program. Public Evaluation of Program A state must identify how to provide the public with an opportunity to review the program through a process that provides for public notice, review, and an opportunity to comment. That can be accomplished through a record of public comments, meetings, forums, or workshops. 5.	The Information Collected-agency Activities, Collection Methodology, and Information Management 5(a)	Agency Activities  The BEACH Act Grant Program will be administered by EPA Headquarters and EPA Regional Offices, which have planned for and allocated resources for the efficient and effective management of the grant program. EPA is conducting the following activities in administering the BEACH Act grants: EPA Headquarters is to monitor state programs annually to ensure compliance with the performance criteria. EPA Regions are to monitor state programs annually to ensure compliance with the performance criteria. EPA Regions and EPA Headquarters are to provide miscellaneous support to the states. EPA Regions are to revise work plans and update the Quality Management Plan. EPA Regions are to perform technical review of a Quality Assurance Project Plan and Grants Management Plan. Regions are to ensure that a Quality Assurance Project Plan is complete before implementation. 5(b)	Collection Methodology and Management  The EPA Beach Program encourages states to electronically transmit beach monitoring and notification data directly to EPA. Electronic reporting is intended to achieve data collection efficiencies and reduce the possibility of data input error. It is the state's responsibility to conduct ongoing data analysis, including performing data quality assurance/quality control to check for anomalies in the data that might be related to data entry or laboratory errors. Data quality review and analysis will include continuous analysis of laboratory results, pollution occurrence events, public notification, and review of all program data. The beach monitoring and notification data will be maintained in the eBEACHES data system. Reporting of beach data to EPA consists of beach program information, notification data, monitoring data, locational data. The data collected under the BEACH Act Grant Program will be used for program performance evaluation to determine if a state program is consistent with the BEACH Guidance and Performance Criteria document, to analyze pollution occurrences at beaches across the nation and report to Congress on the status of the nation's recreation waters. 5(c)	Small Entity Flexibility  Measures to assist small entities are not applicable because the respondents for the BEACH Act Grant Program are state government agencies. However, EPA may make a grant to a local government for implementing a monitoring and notification program only if, after the 1-year period beginning on the date of publication of performance criteria, EPA determines that the state is not implementing a program that meets the performance criteria. 5(d)	Collection Schedule  A state must show evidence documenting its compliance with the nine performance criteria as listed in the Federal Register and the National Beach Guidance and Performance Criteria to be eligible for a BEACH Act Grant. 6.	Estimating the Burden and Cost of the Collection 6(a)	Estimating Respondent Burden  The BEACH Act requires states to devote time and resources to implement a monitoring and notification program to meet the performance criteria outlined in the National Beach Guidance and Performance Criteria for Recreation Waters. To develop burden estimates, EPA estimated the number of hours that will be required by states to adhere to the following performance criteria:    1. Risk-based beach evaluation and classification.    2. Sampling design and monitoring implementation plan.    3. Monitoring report submission and delegation.    4. Methods and assessment procedures.    5. Public notification and risk communication plan.    6. Measures to notify EPA and local governments.    7. Measures to notify the public.    8. Notification report submission and delegation.    9. Public evaluation of program. The Agency estimated that implementing a monitoring and notification program in accordance with the nine performance criteria will take an annual average of 88,812 hours and $3,943,080 O&M for all 37 respondents. The following assumptions were made for this ICR on the basis of data collected by EPA and consultations with respondents listed in section 3(c): The average beach (monitoring) season was assumed to be 18 weeks. The average number of samples collected per week at each monitored beach during the beach season was assumed to be 2 samples. The average cost of sample analysis was assumed to be $30 per sample. The frequency of reporting to EPA is assumed to be quarterly. 6(b)	Estimating Respondent Cost  The annual cost for a state to implement the performance criteria necessary to comply with the BEACH Act Grant Program are attributed to labor costs and O&M costs. The total cost burden over 3 years for the 37 states and territories is estimated to be $25,713,355, which consists of $25,713,355 in labor costs and $11,829,240 in O&M costs.  Labor Costs To develop labor costs, EPA multiplied the number of hours that will be required to implement a monitoring and notification plan by the state employee hourly rate to generate a cost estimate. Because labor rates vary so widely among the state government personnel involved in implementing a state monitoring and notification program, EPA used an average loaded hourly rate that is representative of the average salary for a managerial and technical state employee as listed by the Bureau of Labor Statistics for full-time state and local government workers in the 2010 National Compensation Survey. The managerial salary of $82.58 per hour is calculated as the hourly rate of $51.61 times an overhead factor of 1.6. That is, $51.61 x 1.6) = $82.58. The technical salary of $49.74 per hour is calculated as $31.09 times the 1.6 factor. Table 2 presents an estimate of the burden that state governments will incur to meet each performance criterion outlined in the National Beach Guidance and Grant Performance Criteria for Recreation Waters. The table identifies the activities to be performed by the state, the associated hours required for each activity, and the labor cost for each activity. Annual totals are presented at the end of Table 2.  Operation and Maintenance Costs  In addition to labor costs, the states and territories incur O&M costs associated with the analytical fees and shipping for the water quality samples. Non-labor costs for the 37 states and territories are solely attributed to the laboratory fees that will be charged for analysis and to shipping charges for sending the sample bottles to the appropriate laboratory.   Table 2. Individual respondent 3-year state burden hours   Performance criterion State activity                            3-year  managerial burden                            3-year  technical burden                              Total  3-year burden

                       Total burden per activity (hours)                     Total labor cost $134.19/hour (dollars)                        Total burden per activity (hours)                                Total labor cost                             $80.83/ hour (dollars)                        Total burden per activity (hours)                           Total labor cost (dollars) 1 - Risk-based Beach Evaluation and Classification Identify coastal recreation waters 1 $83 6 $298 7 $381

Identify and submit list of monitored waters 1 $83 6 $298 7 $381

Collect and submit beach lat/long coordinates (georeference beaches using maps, GPS, etc.) 20 $1,652 180 $8,954 200 $10,605

Identify bathing beaches and submit beach miles 20 $1,652 80 $3,980 100 $5,631

Determine legal authority for administering monitoring and notification programs 3 $248 6 $298 9 $546

Review available information 5 $413 15 $746 20 $1,159

Rank beaches 3 $248 100 $4,974 103 $5,222

Performance Criterion 1 Total 53 $4,377 393 $19,549 446 $23,926 2 - Sampling Design and Monitoring Implementation Plan Identify sampling plan (when and where to sample, what depth to sample, etc.) 3 $248 5 $249 8 $496

Ensure data quality 12 $991 100 $4,974 112 $5,965

Staff monitoring programs 4 $330 7 $348 11 $679

Train monitoring staff 16 $1,321 200 $9,949 216 $11,270

Create database and data submission process 40 $3,303 360 $17,908 400 $21,211

Manage data for beach season 20 $1,652 180 $8,954 200 $10,605

Program implementation and oversight 120 $9,909 120 $5,969 240 $15,878

Performance Criterion 2 Total 215 $17,754 972 $48,351 1,187 $66,105 3 - Monitoring Report Submission and Delegation Submit report that describes data collected and public notification activities 12 $991 35 $1,741 47 $2,732

Describe process by which the state may delegate to local governments the responsibility for implementing a monitoring program 6 $495 18 $895 24 $1,391

Performance Criterion 3 Total 18 $1,486 53 $2,636 71 $4,123 4 - Methods and Assessment Procedures Identify laboratories for analysis 1 $83 12 $597 13 $680

Determine analytical procedures 0 $0 4 $199 4 $199

Identify sample collection techniques 1 $83 6 $298 7 $381

Collect water sample 0 $0 1,350 $67,154 1,350 $67,154

Determine data validation and verification procedures 2 $165 9 $448 11 $613

Analyze and submit monitoring data to EPA 140 $11,561 2,600 $129,334 2,740 $140,895

Identify the use of predictive tools in beach monitoring. (If using predictive tools, identify what type of tool, how used, how applicable, etc.) 4 $330 20 $995 24 $1,325

Performance Criterion 4 Total 148 $12,221 4,001 $199,026 4,149 $211,247 5 - Public Notification and Risk Communica-tion Plan Perform a problem assessment and audience identification 2 $165 22 $1,094 24 $1,260

Determine and develop content and procedures for advisories and closings 4 $330 44 $2,189 48 $2,519

Performance Criterion 5 Total 6 $495 66 $3,283 72 $3,779 6 - Measures to Notify EPA and Local Governments Determine the mechanisms for states to notify local governments of advisories and closings, and removal of advisories and closings 3 $248 23 $1,144 26 $1,392

Determine the mechanisms for states to notify EPA of advisories, closings, and removal of advisories and closings  1 $83 13 $647 14 $729

Collect and submit notification data to EPA 4 $330 22 $1,094 26 $1,425

Performance Criterion  6 Total 8 $661 58 $2,885 66 $3,546 7 - Measures to Notify the Public Determine the mechanisms for states to notify the public of advisories, closings, and removal of advisories and closings 2 $165 20 $995 22 $1,160

Implement notification program (could include posting signs or functional equivalent) 45 $3,716 855 $42,531 900 $46,247

Performance Criterion 7 Total 47 $3,881 875 $43,526 922 $47,407 8 - Notification Report Submission and Delegation Submit report that describes data collected and the public notification activities 6 $495 50 $2,487 56 $2,983

Describe process by which the state may delegate to local governments the responsibility for implementing a notification program  2 $165 22 $1,094 24 $1,260

Performance Criterion 8 Total 8 $661 72 $3,582 80 $4,242 9 - Public Evaluation of Program Ensure the monitoring and notification program meets the needs of the audiences and the objectives of the Agency 8 $661 96 $4,775 104 $5,436

Evaluate the monitoring and notification program 8 $661 96 $4,775 104 $5,436

Performance Criterion 9 Total 16 $1,321 192 $9,551 208 $10,872 Total 519 $42,857 6,682 $332,389 7,201 $375,246 Annual Total 173 $14,286 2,227 $110,796 2,400 $125,082

The O&M costs were calculated as an average for the 3,651 coastal and Great Lakes beaches identified in EPA's 2010 National Beaches Survey (the most recent version available) for the 37 states and territories eligible to participate in the BEACH Act Grant Program. EPA obtained laboratory fees and shipping costs from testing labs and estimated the cost to be $30 per sample. The cost for each state was calculated using the equation below: 3,651 beaches x 36 samples (twice per week for 18 week season) x $30/sample =  $106,570/state                                    37 states EPA estimates an annual O&M cost of $106,570 per state, an annual total O&M cost of $3,943,080 for all 37 states, and a total O&M cost of $11,829,240 for 37 states over 3 years. 6(c)	Estimating Agency Burden and Cost  The BEACH Act requires EPA to devote time and resources to manage the grant program. To develop burden estimates, EPA estimated the number of hours that will be required to administer the program. The Agency estimates that it will take 85 hours per respondent to review and process the applications, monitor respondent programs, and provide miscellaneous support. When multiplied by 37 respondents, the annual Agency burden is 3,145 hours to administer the program and a total Agency burden of 9,435 hours over 3 years. The Agency used an average hourly salary for Agency employees of $65.94, which was calculated using an hourly rate of $41.21 plus an overhead factor of 60%. That is, $41.21 x 1.6 = $65.94. The labor rate was obtained using 2011 salary tables provided by the Office of Personnel Management. Table 3 presents an estimate of the burden that EPA will incur to manage the BEACH Act Grant Program for years 1 through 3 of this ICR. The annual totals are presented at the bottom of the table. Table 3. Total Agency burden hours per activity over 3 years  Activities                               Agency burden hours                              Agency burden dollars EPA Headquarters to monitor state programs annually to ensure compliance with the performance criteria.                                      1,480                                     $97,591 EPA Regions to monitor state programs annually to ensure compliance with the performance criteria.                                      2,035                                    $134,188 EPA Headquarters and EPA Regions to provide miscellaneous support to states.                                       1,480                                     $97,591 EPA Regions to revise work plans and update beach monitoring and notification program procedures.                                       1,268                                     $83,612 EPA Regions to perform technical review on Quality Assurance Project Plan and Grants Management Plan, DQOs and SOPs prior to implementation.                                      3,172                                    $209,162 Total over 3 years                                      9,435                                    $622,144 Annual total                                      3,145                                    $207,381

6(d)	Estimating the Respondent Universe and Total Burden and Costs  Table 4 presents an estimate of the total respondent burden and costs expected for the BEACH Act Grant Program. The total annual respondent burden is expected to be 88,812 hours and $3,943,080 O&M Costs. There are no start-up costs.  Table 4. Annual respondent burden and cost                               Performance criteria                              Respondent hours/year                           Respondent labor cost/year                                O&M cost/year                           Number of respondents/year                                Total hours/year                                Total cost/year*                                        1 148.67 $7,975

37                                      5,501                                                                       $295,086                                         2 395.67 $22,035

37                                     14,640                                                                       $815,295                                         3 23.67 $1,374

37                                       876                                                                        $50,848                                         4 1,383.00 $70,416

37                                     51,171                                                                     $2,605,380                                         5 24.00 $1,260

37                                       888                                                                        $46,602                                         6 22.00 $1,182

37                                       814                                                                        $43,731                                         7 307.33 $15,802

37                                     11,371                                                                       $584,687                                         8 26.67 $1,414,06

37                                       987                                                                        $52,320                                         9 69.33 $3,624

37                                      2,565                                                                       $134,089                                       Total 2,400.33 $125,082 $3,943,080 37                                     88,812                                                                     $8,571,118  *Values might not add up exactly due to rounding. 6(e)	Bottom Line Burden Hours and Cost Tables  Table 5 presents an estimate of the total annual State and Agency burden and costs expected for the BEACH Act Grant Program. As shown in Table 5, the annual burden for the Agency and 37 states, tribes, and territories with coastal recreation waters is 91,957 hours and $8,778,500 including O&M costs. Table 5. Total annual respondent and Agency burden and costs

                                Burden (hours)                                  Burden cost*                                  O&M cost                                   Total cost* 37 States 88,812 $4,628,038 $3,943,080 $8,571,118 Agency 3,145 $207,381 $0 $207,381 Total 91,957 $4,835,420 $3,943,080 $8,778,500 *Values might not add up exactly due to rounding. 6(f)	Reasons for Change in Burden  The respondent average annual burden increased from the 2008 level of 2,374 hours to 2,400 hours for the total number of 37 respondents. The Agency annual burden decreased from the 2008 level of 3,200 hours to 3,145 hours. EPA used 37 for the number of respondents (37 currently receive BEACH Act grants) compared to 40 respondents used in the 2008 ICR. EPA used 40 for the number of respondents in the 2008 ICR because the Agency expected additional tribes to apply for BEACH Act grants that had not done so during the original ICR period. However, no additional tribes applied for grants. Therefore, for this ICR renewal EPA used the actual number (37) of states, territories, and tribes that currently receive BEACH Act grants. The increase in respondent burden is because EPA is encouraging states to voluntarily report monitoring and notification data more frequently, up to four times each year. The increase in burden is minimized, however, because respondents have become more efficient in their reporting of data and information over the past several years and EPA has made improvements to the eBEACHES data system. The annual O&M costs for all respondents also increased from $3,938,760 to $3,943,080 for all states. That is because the estimated number of beaches monitored by grant recipients increased slightly from 3,647 (estimated from EPA's 2007 National List of Beaches) to 3,651 (estimated from the 2010 Annual Swimming Season Report). Relative to the 2008 ICR, EPA maintained its estimate of two samples collected each week per monitored beach with a beach season length of 18 weeks and sample cost of $30 per sample, according to data that EPA collected and comments received from several state Beach Program contacts and testing labs. EPA also revised the labor rates, which increased from $47.00 to 51.61 for a managerial employee and decreased from $31.25 to $31.09 for a technical employee according to the average Bureau of Labor Statistics salaries for managerial and technical employees in state and local governments as shown in its 2010 National Compensation Survey Table.  6(g)	Burden Statement  The annual public reporting and recordkeeping burden for this collection of information is estimated to average 2,400 hours per response. 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. That includes the time needed to review instructions; develop, acquire, install, and use 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 Part 15.   	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. EPA-HQ-OW-2008-0357, which is available for public viewing at the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 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 Water Docket is<PHONE_NUMBER>. An electronic version of the public docket is available through Regulations.gov at http://www.regulations.gov/. 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, use the Regulations.gov website. Once there, click 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. EPA-HQ-OW-2008-0357 and OMB control number 2040-0244 in any correspondence.


[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12501-12503]
[FR Doc No: 2016-05213]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0049]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reporting Harmful and
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
Under the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by April
8, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0732.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Reporting Harmful and Potentially Harmful Constituents in Tobacco
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic
Act OMB Control Number 0910-0732--Extension

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Pub. L. 111-31) into law. This law
amended the Food Drug and Cosmetic Act (the FD&C Act) and granted FDA
authority to regulate the manufacture, marketing, and distribution of
tobacco products to

protect public health generally and to reduce tobacco use by minors.
Section 904(a)(3) of the FD&C Act (21 U.S.C. 387d(a)(3)) required each
tobacco product manufacturer or importer, or an agent, to begin
reporting to FDA no later than June 22, 2012, ``all constituents,
including smoke constituents as applicable, identified by FDA as
harmful or potentially harmful to health in each tobacco product, and
as applicable in the smoke of each tobacco product.'' Reports must be
by the brand and by quantity in each brand and sub-brand. Section
904(c)(1) of the FD&C Act states that manufacturers of tobacco products
not on the market as of June 22, 2009, must also provide information
reportable under section 904(a)(3) at least 90 days prior to
introducing the product into interstate commerce.
    FDA has taken several steps to identify harmful and potentially
harmful constituents (HPHCs) to be reported under sections 904(a)(3)
and (c)(1) of the FD&C Act, including issuing a guidance discussing
FDA's current thinking on the meaning of the term ``harmful and
potentially harmful constituent'' in the context of implementing the
HPHC list requirement under section 904(e) of the FD&C Act (76 FR 5387,
January 31, 2011). The guidance is available on the Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm.
    In addition, in the Federal Register of April 3, 2012 (77 FR
20034), FDA published a notice (the HPHC list notice) announcing the
established list of HPHCs as required by section 904(e) of the FD&C Act
and describing the criteria we used in identifying the HPHCs for the
established list. Previously, FDA sought comment on both the criteria
that would be used to identify HPHCs for the established list and a
list of chemicals and chemical compounds that met the proposed
criteria.
    The purpose of the information collection is to collect statutorily
mandated information regarding HPHCs in tobacco products and tobacco
smoke, by quantity in each brand and sub-brand.
    To facilitate the submission of HPHC information, FDA has developed
Forms 3787a, 3787b, and 3787c in both paper and electronic formats.
Manufacturers or importers, or their agents, may submit information
either electronically or in paper format. The FDA eSubmitter tool
provides electronic forms to streamline the data entry and submission
process for reporting HPHCs. Users of eSubmitter may populate an FDA-
created Excel file and import data into eSubmitter. Whether respondents
decide to submit reports electronically or on paper, each form provides
instructions for completing and submitting HPHC information to FDA. The
forms contain fields for company information, product information, and
HPHC information. Respondents finished reporting initial HPHC
information under section 904(a)(3) in 2012, and this collection of
information is in connection with the reporting requirements under
section 904(c)(1) of the FD&C Act for tobacco products introduced into
interstate commerce after June 22, 2009.
    In the Federal Register of November 13, 2015 (80 FR 70232), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Four comments were received; however, only
one was PRA related.
    A comment stated that FDA has dramatically underestimated the
annual number of responses that will be submitted from tobacco product
manufacturers and importers. The comment contended that our estimate
does not appear to be based on the Agency's experience with respect to
``new'' tobacco product submissions under section 910 of the FD&C Act.
    We have reconsidered our estimates, and agree with what we
understand the comment to be saying, that we have not accounted for the
submission of the two streamlined alternative substantial equivalent
(SE) reports, one for label changes and one for product quantity
changes, referred to as the ``Same Characteristics SE Report'' and the
``Product Quantity Change SE Report,'' respectively, and subsequent
premarket authorization for a ``new tobacco product'' as defined under
section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1)). Based on FDA
data, we estimate between 500 and700 (i.e., approximately 600) new
tobacco products annually, as a result of manufacturers and importers
submitting these streamlined submissions. We also estimate that the
report of HPHC data in connection with these new tobacco products will
take approximately 1 hour to prepare and submit. FDA has added a new
line in the table for this category of new tobacco products.
    A comment also stated that the burden estimated for testing the
quantities of HPHCs in cigarette filler and roll-your-own, smokeless,
and smoke as 9.42 hours, 12.06 hours and 23.64 hours respectively, per
product, has been dramatically underestimated. The comment contends
that HPHC testing may more realistically be expected to take 7 to 12
weeks per product. FDA does not agree with this comment. The Agency
based its estimates on its understanding as to how long the tests
themselves take, as opposed to the length of time between when a
manufacturer or importer may first request that a test be done and then
receives the test results from an internal or independent laboratory.
    Furthermore, a comment stated that the burden estimated for the
time required to report HPHC information to the Agency has been
underestimated. The comment contends that in one entity's experience,
the time required to report on the testing of a cigarette may be
expected to take around 200 hours, taking into account the time
required to compile the requisite information and to complete, review
and edit the associated form.
    FDA disagrees with this comment as we believe the estimates for
testing the quantities of HPHCs are accurate. Additionally, we note
that the comment did not contain any data to support its contention.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
     Information collected         Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
                                    Reporting for Section 904(c)(1) Products
----------------------------------------------------------------------------------------------------------------
1. Reporting of Manufacturer/
 Importer Company and Product
 Information by Completing
 Submission Forms:
    Cigarette.................              78            0.79              62  1.82............             113
    Roll-Your-Own.............              39            0.21               8  0.43 (26                       3
                                                                                minutes).
    Smokeless.................              52            0.21              11  0.63 (38                       7
                                                                                minutes).
                               ---------------------------------------------------------------------------------

        Total.................  ..............  ..............  ..............  ................             123
2. Testing of HPHC Quantities
 in Products:
    Cigarette Filler..........              78            0.79              62  9.42............             584
    Roll-Your-Own.............              39            0.21               8  9.42............              75
    Smokeless.................              52            0.21              11  12.06...........             133
                               ---------------------------------------------------------------------------------
        Total.................  ..............  ..............  ..............  ................             792
3. Testing of HPHC Quantities
 in Mainstream Smoke:
    Cigarette: International                78            0.79              62  23.64...........           1,466
     Oraganization for
     Standardization (ISO)
     Regimen.
    Cigarette: Health Canada                78            0.79              62  23.64...........           1,466
     Regimen.
                               ---------------------------------------------------------------------------------
        Total.................  ..............  ..............  ..............  ................           2,932
4. Additional HPHC reports:
 \2\
    Cigarette Filler..........              78            2.56             200  1...............             200
    Roll-Your-Own.............              39            5.12             200  1...............             200
    Smokeless.................              52            3.84             200  1...............             200
                               ---------------------------------------------------------------------------------
        Total.................  ..............  ..............  ..............  ................             600
                               ---------------------------------------------------------------------------------
            Total Section       ..............  ..............  ..............  ................           4,447
             904(c)(1)
             Reporting Burden
             Hours.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ HPHC reports for identical products (e.g., under different brand or sub-brand names) in which the HPHC
  measures will be the same as the original report.

    Table 1 contains estimates for new product information received
annually under section 904(c)(1) of the FD&C Act. Manufacturers must
report HPHC information under section 904(c)(1) of the FD&C Act at
least 90 days prior to delivery for introduction into interstate
commerce. The total annual burden for this collection of information is
estimated to be 4,447 hours. The burden estimate for this collection of
information includes the time it will take to test the products and
prepare the HPHC report. Table 1 indicates that 169 respondents will
submit HPHC reports when new products enter the market.
    Section 1 of the table addresses the time required for
manufacturers to report their company information. We estimate that the
time to report HPHC information is no more than 1.82 hours for
cigarettes, 0.42 hours for roll-your-own, and 0.63 hours for smokeless
tobacco products for each response regardless of whether the paper or
electronic form (Form FDA 3787) is used. (The estimated times to report
smokeless tobacco products (0.63 hour) and roll-your-own tobacco
products (0.43 hour) are lower than the estimated reporting time for
cigarette products because fewer HPHCs are normally reported for these
two types of products. The total annual burden for reporting company
and product information is 123 hours.
    Section 2 of the table addresses the time required for
manufacturers to test quantities of HPHCs in their products. The burden
hour estimates include the time needed to test the tobacco products,
draft testing reports, and draft the report for FDA. For cigarette
filler, smokeless, and roll-your-own products, we estimate the burden
to be 792 annual burden hours. The burden for each product type
reflects our estimate of the time to test the tobacco products (i.e.,
carry out laboratory work).
    In addition to addressing the time required to report information
and test quantities of HPHCs in tobacco products, section 3 of table 1
addresses the time required for manufacturers to test quantities of
HPHCs in cigarette smoke. The burden estimates include testing the
tobacco products, drafting testing reports, and drafting the report for
FDA. We estimate the annualized burden for this section to be 2,932
hours. The annual burden reflects our estimate to test the tobacco
products (i.e., carry out laboratory work). The burden estimate assumes
that manufacturers report HPHC quantities in cigarette mainstream smoke
according to the two smoking regimens described in the table.
    As stated previously, FDA expects to receive 600 additional HPHC
reports at 1 hour per response for a total of 600 hours. The estimated
total annual burden for the reporting of HPHC under section 904(c)(1)
of the FD&C Act is 4,447 hours.

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05213 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 74, Number 94 (Monday, May 18, 2009)]
[Proposed Rules]
[Pages 23131-23133]
[FR Doc No: E9-11478]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0545; Directorate Identifier 2008-NE-16-AD]
RIN 2120-AA64

Airworthiness Directives; Dowty Propellers Models R354/4-123-F/
13, R354/4-123-F/20, R375/4-123-F/21, R389/4-123-F/25, R389/4-123-F/26,
and R390/4-123-F/27 Propellers

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
the comment period.

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

SUMMARY: This supplemental NPRM revises an earlier proposed
airworthiness directive (AD), applicable to Dowty Propellers Models
R354/4-123-F/13, R354/4-123-F/20, R375/4-123-F/21, R389/4-123-F/25,
R389/4-123-F/26, and R390/4-123-F/27 propellers. That proposed AD would
have required initial and repetitive visual inspections of propeller
blade root outer sleeves for cracks, and removal before further flight
of propeller blades with cracked blade root outer sleeves. That
proposed AD resulted from mandatory continuing airworthiness
information (MCAI) issued by the European Aviation Safety Agency (EASA)
to identify and correct an unsafe condition on certain Dowty
propellers. This supplemental NPRM revises the proposed AD to correct
the listing of propeller models affected. This supplemental NPRM
results from the discovery that we need to correct one of the propeller
model numbers affected, and to remove an erroneous propeller model
number. We are proposing this AD to prevent blade counterweight
release, which could result in injury or damage to the airplane. The
MCAI describes the unsafe condition as:

    A number of propeller blade outer sleeves have been found with
cracks since 1996. Testing has shown that blade retention integrity
is not affected by this cracking. However, this condition, if not
detected and corrected, can lead to blade counterweight release,
possibly resulting in damage to the aircraft and injury to occupants
or persons on the ground.

    We are proposing this AD to prevent blade counterweight release,
which could result in injury or damage to the airplane.

DATES: We must receive comments on this proposed AD by June 17, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Terry Fahr, Aerospace Engineer, Boston
Aircraft Certification Office, FAA, Engine and Propeller Directorate,
12 New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0545;
Directorate Identifier 2008-NE-16-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Community, has issued EASA AD 2008-0033, dated February 19,
2008, to correct an unsafe condition for the specified products. The
EASA AD states:

    A number of propeller blade outer sleeves have been found with
cracks since 1996. Testing has shown that blade retention integrity
is not affected by this cracking. However, this condition, if not
detected and corrected, can lead to blade counterweight release,
possibly resulting in damage to the

aircraft and injury to occupants or persons on the ground.

    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Dowty Propellers has issued Alert Service Bulletin No. SF340-61-
A106, Revision 1, dated March 20, 2008. The actions described in this
service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of the
United Kingdom, and is approved for operation in the United States.
Pursuant to our bilateral agreement with the United Kingdom, they have
notified us of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all information provided by EASA and determined the unsafe
condition exists and is likely to exist or develop on other products of
the same type design. This Supplemental NPRM requires initial and
repetitive visual inspections of propeller blade root outer sleeves for
cracks, and removal before further flight of propeller blades with
cracked blade root outer sleeves.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received on the original NPRM.

Request To Reference the Latest Service Bulletin

    One commenter, Colgan Air, requests that we reference the latest
service bulletin, which is Dowty Propellers Alert Service Bulletin No.
SF340-61-A106, Revision 1, dated March 20, 2008.
    We agree and changed that reference in this Supplemental NPRM.

Request To Clarify Airplane Manufacturer

    One commenter, SAAB AB, SAAB Aerosystems, requests that we clarify
that ``340B airplanes'' should be referred to as ``SAAB 340B
airplanes''.
    We agree and clarified that reference in this Supplemental NPRM.

Need To Correct the Listing of Propeller Models Affected

    We discovered the need to correct the listing of the propeller
models affected that was included in the original NPRM published in the
Federal Register on June 30, 2008 (73 FR 36819). That listing, which is
Dowty Propellers models R354/4-123-F/13, R354/4-123-F/20, R354/4-123-F/
21, R375/4-123-F/21, R389/4-123-F/25, R354/4-123-F/26, and R390/4-123-
F/27 propellers, is changed in this Supplemental NPRM to Dowty
Propellers Models R354/4-123-F/13, R354/4-123-F/20, R375/4-123-F/21,
R389/4-123-F/25, R389/4-123-F/26, and R390/4-123-F/27 propellers.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require making
the changes described previously. We determined that these changes will
not increase the economic burden on any operator or increase the scope
of the Supplemental NPRM.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 292 propellers installed on airplanes of U.S.
registry. We also estimate that it would take 0.5 work-hour per
propeller to visually inspect for cracks. The average labor rate is $80
per work hour. Based on these figures, we estimate the cost of the
proposed AD on U.S. operators to be $11,680.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Dowty Propellers: Docket No. FAA-2008-0545; Directorate Identifier
2008-NE-16-AD.

Comments Due Date

    (a) We must receive comments by June 17, 2009.

Affected Airworthiness Directives (ADs)

    (b) None.

Applicability

    (c) This AD applies to Dowty Propellers Models R354/4-123-F/13,
R354/4-123-F/20, R375/4-123-F/21, R389/4-123-F/25, R389/4-123-F/26,
and R390/4-123-F/27 propellers. These propellers are installed on,
but not limited to, Saab AB, Saab Aerosystems SF340A and SAAB SF340B
airplanes.

Reason

    (d) European Aviation Safety Agency (EASA) AD No. 2008-0033,
dated February 19, 2008, states:
    A number of propeller blade outer sleeves have been found with
cracks since 1996. Testing has shown that blade retention integrity
is not affected by this cracking. However, this condition, if not
detected and corrected, can lead to blade counterweight release,
possibly resulting in damage to the aircraft and injury to occupants
or persons on the ground.

    This AD requires initial and repetitive visual inspections of
propeller blade root outer sleeves for cracks, and removal before
further flight of propeller blades with cracked blade root outer
sleeves. We are issuing this AD to prevent blade counterweight
release, which could result in injury or damage to the airplane.

Actions and Compliance

    (e) Unless already done, do the following actions.

Propeller Blade Root Outer Sleeve Visual Inspections

    (1) At the next 1,600 flight hours (FH) aircraft check after the
effective date of this AD, or, after any blade accumulates 15,000 FH
time-in-service, whichever occurs later, visually inspect all
propeller blade root outer sleeves for cracks.
    (2) Thereafter, at intervals not to exceed 1,600 FH, visually
inspect all propeller blade root outer sleeves for cracks.
    (3) Before further flight, remove any propeller blades found
with cracked root outer sleeves during the visual inspections in
paragraphs (e)(1) and (e)(2) of this AD.

FAA AD Differences

    (f) None.

Alternative Methods of Compliance (AMOCs)

    (g) The Manager, Boston Aircraft Certification Office, FAA,
Engine and Propeller Directorate, has the authority to approve AMOCs
for this AD, if requested using the procedures found in 14 CFR
39.19.

Related Information

    (h) Refer to European Aviation Safety Agency AD 2008-0033, dated
February 19, 2008, and Dowty Propellers Alert Service Bulletin No.
SF340-61-A106, Revision 1, dated March 20, 2008, for related
information.
    (i) Contact Terry Fahr, Aerospace Engineer, Boston Aircraft
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>,
for more information about this AD.

    Issued in Burlington, Massachusetts, on May 8, 2009.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E9-11478 Filed 5-15-09; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 31, 2006 (Volume 71, Number 20)]
[Notices]
[Page 5092-5093]
[DOCID:fr31ja06-77]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53175; File No. SR-CBOE-2005-101]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Inc.; Order Approving a Proposed Rule Change Relating to Membership
Rules

January 25, 2006.

I. Introduction

    On November 29, 2005, the Chicago Board Options Exchange,
Incorporated (``CBOE'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'' or ``SEC''), pursuant to Section
19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change seeking to modify CBOE Rule
3.9, relating to investigation of membership applicants.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    The proposed rule change was published in the Federal Register on
December 22, 2005.\3\ The Commission received no comments on the
proposed rule change. On January 23, 2006, the Exchange submitted
Amendment No. 1 to the proposed rule change.\4\ This order approves the
proposed rule change, as amended by Amendment No 1.

II. Description

    The Exchange is proposing to amend CBOE Rule 3.9 (``Application
Procedures and Approval or Disapproval'') subsection (f), which
currently requires CBOE's Membership Department to investigate each
applicant applying to be a member organization, each associated person
required to be approved by the Membership Committee pursuant to CBOE
Rule 3.6(b), and each applicant applying to be an individual member
(collectively ``Membership Applicants''). As part of the current
application process, Membership Applicants are required to submit
fingerprints to the Exchange,\5\ which CBOE then forwards to the
Federal Bureau of Investigation.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 52952 (December 14,
2005), 70 FR 76087.
    \4\ In Amendment No. 1, the Exchange proposed an additional
modification to CBOE Rule 3.9(f). Specifically, the Exchange
proposed a change so that, as amended, the proposed rule would
permit the Exchange to rely on the results of a fingerprint-based
criminal records check of an applicant conducted by the Exchange
itself, in addition to a check conducted by another self-regulatory
organization (``SRO''), within the prior year. Amendment No. 1 is a
technical amendment and therefore not subject to notice and comment.
    \5\ See CBOE Rule 3.7(c).
---------------------------------------------------------------------------

    The Exchange currently requires Membership Applicants to submit new
fingerprints to the Exchange for processing, as part of the
investigation process pursuant to CBOE Rule 3.9(f), even if the
Membership Applicant was recently fingerprinted at the Exchange or
another SRO. The proposed rule change would change this requirement to
permit the Exchange to accept the results of a fingerprint-based
criminal records check of the Membership Applicant conducted by the
Exchange or another SRO within the prior year pursuant to that
investigation process.

III. Discussion

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.\6\
In particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act \7\ which requires, among
other things, that the rules of an exchange be designed to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market, and to protect investors and
the public interest.
---------------------------------------------------------------------------

    \6\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In approving this proposed rule change, the Commission notes that
as part of the application process, in addition to a fingerprint-based
criminal records check, CBOE requires that a Membership Applicant also
submit a Form U-4 (Uniform Application for Securities Industry
Registration or Transfer). Form U-4 requires disclosure of events that
would constitute a statutory disqualification under the Act. Because
the Exchange obtains this information as part of the application
process, and because CBOE Rule 3.9(d) requires Membership Applicants to
promptly update membership application materials if the information
provided in the materials becomes inaccurate or incomplete after the
date of submission, the Commission believes that it is reasonable for
the Exchange to expect that its Membership Department would have access
to information that would reveal whether a Membership Applicant became
subject to a statutory disqualification subsequent to the date of the
results of a fingerprint-based criminal records check conducted either
by the Exchange or by another SRO on which CBOE would be relying.

IV. Conclusion

    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder.
    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\8\ that the proposed rule change (SR-CBOE-2005-101) is approved,
as amended.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).

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

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
Nancy M. Morris,
Secretary.
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. E6-1163 Filed 1-30-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: March 29, 2007 (Volume 72, Number 60)]
[Notices]
[Page 14791]
[DOCID:fr29mr07-70]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 199-205]

Santee Cooper Hydroelectric Project; Notice of Availability of
the Draft Environmental Impact Statement for the Santee Cooper
Hydroelectric Project and Intention to Hold Public Meeting

March 23, 2007.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission (Commission or FERC)
regulations contained in the Code of Federal Regulations (CFR) (18 CFR
part 380 [FERC Order No. 486, 52 FR 47897]), the Office of Energy
Projects staff (staff) reviewed the application for a New Major License
for the Santee Cooper Hydroelectric Project, and have prepared a draft
environmental impact statement (DEIS) for the project which is located
on the Santee and Cooper Rivers in Berkeley, Calhoun, Clarendon,
Orangeburg, and Sumpter Counties, South Carolina.
    The DEIS contains staff's analysis of the applicant's proposal and
the alternatives for relicensing the Santee Cooper Hydroelectric
Project. The DEIS documents the views of governmental agencies, non-
governmental organizations, affected Indian tribes, the public, the
license applicant, and Commission staff.
    A copy of the DEIS is available for review at the Commission or may
be viewed on the Commission's Web site at http://www.ferc.gov, using

the ``e-Library'' link. Enter the docket number, excluding the last
three digits, to access the document. For assistance, contact FERC
Online Support at<EMAIL_ADDRESS>or toll-free at (866)208-
3676, or for TTY, contact<PHONE_NUMBER>.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    Comments should be filed with Philis J. Posey, Acting Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. All Comments must be filed within 60 days of the
date of this notice, and should reference the Santee Cooper
Hydroelectric Project, Project No. 199-205. Comments may be filed
electronically via the internet in lieu of paper. The Commission
strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii)
and instructions on the Commission's Web site at http://www.ferc.gov

under the eLibrary link.
    Anyone may intervene in this proceeding based on this DEIS (18 CFR
380.10). You must file your request to intervene as specified above.\1\
You do not need intervenor status to have your comments considered.
---------------------------------------------------------------------------

    \1\ Interventions may also be filed electronically via the
Internet in lieu of paper. See the previous discussion on filing
comments electronically.
---------------------------------------------------------------------------

    In addition to or in lieu of sending written comments, you are
invited to attend a public meeting that will be held to receive
comments on the DEIS. The time and place of the meeting is as follows:
    Date: Wednesday, May 2, 2007.
    Time: 7:30 PM (EDT).
    Place: Holiday Inn Express.
    Address: 505 R.C. Dennis Blvd., Moncks Corner, SC.
    At this meeting, resource agency personnel and other interested
persons will have the opportunity to provide oral and written comments
and recommendations regarding the DEIS. The meeting will be recorded by
a court reporter, and all statements (verbal and written) will become
part of the Commission's public records for the project. This meeting
will be posted on the Commission's calendar located at http://www.ferc.gov/EventCalendar/Eventslist.aspx
 along with other related

information.
    For further information, please contact Monte TerHaar at (202) 502-
6035 or at<EMAIL_ADDRESS>
Philis J. Posey,
Acting Secretary.
 [FR Doc. E7-5697 Filed 3-28-07; 8:45 am]

BILLING CODE 6717-01-P


MEMORANDUM April 27, 2004 SUBJECT: Science Chapter on: Environmental Fate Studies and Environmental Fate Assessment of Pine Oil FROM A. Najm Shamim, Ph. D., Chemist Regulatory Management Branch II Antimicrobials Division ( 7510C)

To: Ben Chambliss, Acting Team Leader Regulatory Management Branch II Antimicrobials Division ( 7510C)

And Michelle Centra, Pharmacologist, And Science Coordinator For Dipropylene Glycol RED Regulatory Management Branch II Antimicrobials Division ( 7510C)

Thru: Connie Welch, Chief Regulatory Management Branch II Antimicrobials Division ( 7510C)

Environmental Fate Science Chapter and Fate Assessment on Pine Oil is submitted for Reregistration Eligibility Decision ( RED). Page 2 of 7 EXECUTIVE SUMMARY Environmental Fate Assessment of Pine oil:

Pine oil's pesticidal use as a disinfectant, santizer, microbicide/ microbistat, virucide, and insecticide are mainly indoor use products and would have a low probability of surface or ground water contamination. Pine oil as registered with the Agency has several different blends, but the major components of Pine oil are alpha terpineol and alpha and beta Pinene. The registrants have submitted data on Pine Oil Blend 110990, which is a composite blend of 100% pine oil MUPs of 84% terpene alcohols ( of which alpha terpineol is a major constituent) and up to 16% terpene hydrocarbons, of which alpah/ beta pinenes are a major constituent. Since the registered product is a mixture and no fate data were submitted and since no open literature data are available on fate characteristics of pine oil, the Agency decided to make a comparison of fate properties of alpha/ beta pinenes, and alpha terpineol and extrapolate these to pine oil under consideration for reregistration.

Alpha and beta pinene may exist as a vapor in the ambient atmosphere and will be degraded by reaction with photochemically mediated hydroxyl radicals with a half life of 4 hours and 4.9 hours, respectively. Alpha and beta pinene are not expected to directly photolyze due to the lack of absorption in the environmental UV spectrum. Alpha and beta pinene volatilize in both soil and surface water. These undergo biodegradation readily and have low mobility in soil possibly have low probability of ground and surface water contamination. Alpha and betapinene's bioconcentration factors of 2800 and 440, respectively, and high log K ow values may result in bioaccumulation or bioconcentration in aquatic organisms. However, a recent paper3 ( National Park Service of Colorado and Colorado State University) suggests that turpentine oil ( of which alpha/ beta pinenes constitute up to 90% do not appear to bioaccumulate, possibly due to readily biodegradable property. Alpha and beta pinene have also been shown to be readily biodegradable in the soil by microorganisms, although both alpha and beta pinene absorb with a high degree to suspended particles and sediments in the water column having an estimated K oc ( 1000 and 1200, respectively).

Environmental Fate Assessment ( alpha terpineol):

Alpha terpineol most likely exists as a vapor in the ambient atmosphere and is degraded by reaction with photochemically mediated hydroxyl radicals with a half life of 4 hours. Alphaterpineol does not hydrolyze or go through direct photolysis due to the lack of absorption in the environmental UV spectrum. Alpha Terpineol volatilizes in both soil and surface water. Along with volatilization, it is highly bio biodegradable and with low mobility in soil it is not likely to contaminate ground and surface water. Alpha terpineol's bioconcentration factor 110 and a log K ow value may possibly result in moderate bioaccumulation and bioconcentration in aquatic organisms. However, no data on aquatic organisms are available. Alpha terpineol also readily degrades in the soil by microorganisms. Alpha terpineol has a high absorptitivty to suspended particles and sediments in the water column as its estimated K oc ( 1000). Page 3 of 7 The registered product of pine oil appear to have some differences in physical properties like it is not water soluble, hence no Kow can be estimated and is not known. Similarly, its vapor pressure is different ( 0.20 mm Hg at 20 o C) from alpha/ beta pinenes or alpha terpineol, ( 4.93 and 2.98 for alpha/ beta pinenes vs 4.2 x 10 2 mm Hg for alpha terpineol). Alpha/ beta pinenes and alpha terpineol as separate entities do not show any major environmental concerns, and the Agency at this time has determined that pine oil is not likely to have any major environmental concerns Environmental Fate Chemistry of alpha and beta pinene :

The Agency does not have a database on alpha and beta pinene in environmental media. For the reregistration eligibility decision ( RED) process the Agency has relied on open literature and fate properties of alpha and beta pinene obtained from open literature. The following fate properties from an open literature search are ( 1,2)

Environmental Fate Properties of alpha and beta pinene alpha pinene beta pinene Vapor Pressure @ 25o C ( mm Hg) 4.75 2.93 Henry's Law Constant ( air/ water partition coefficient) ( atm cu m/ mole) 0.107 0.160 K OC ( organic carbon ratio in soil) 1000 1200 Log K OW ( octanol/ water partition coefficient) 4.83 4.35 BCF 2800 440 Alpha pinene 1. Exists solely as a vapor in the ambient atmosphere and will be degraded by reaction with photochemically produced hydroxyl radicals ( half life for reaction: 4 hrs). 2. Degraded in atmosphere by reaction with ozone ( half life for reaction: 40 minutes). 3. Degraded by a night time reaction with nitrate radicals ( half life for reaction: 6 minutes) 4. Not expected to directly photolyze due to the lack of absorption in the environmental UV spectrum.

1. Abiotic Degradation:

a. Hydrolysis: Not expected to occur due to the lack of hydrolyzable functional groups. Page 4 of 7 b. Photolysis: Alpha pinene not expected to directly photolyze due to the lack of absorption in the environmental UV spectrum. Products from the reaction of alpha pinene with ozone are carbon monoxide, cabon dioxide, formaldehyde, acetaldehyde, formic acid, peroxyacteylnitrate, cis pinonic acid, nopinene, acetone, pionaldehyde, glyoxal, and hydroxyl radicals.

2. Biotic Degradations:

a. Aqueous aerobic degradation: The biodegradation in aerobic waters is expected to be rapid based on the results of screening studies. The concentration of alphapinene in sea water samples decreased from 0.41 ng/ L to 0.25 ng/ L when incubated with macrophytes for 6 hours at 10oC. The concentration of alphapinene in the influent to a kraft mill aerated stabilization basin with a 7 8 day retention time decreased from 0.20 ppm to 0.04 ppm.

b. Aqueous Anaerobic degradation: No literature studies are available.

c. Aerobic soil degradation: Rapid degradation is expected based on soil slurry samples taken from three different Georgia watersheds that were found to readily degrade alpha pinene under aerobic conditions undergoing complete removal within 250 hours after short lag period.

Bioaccumulation: Log K ow of this chemical is estimated to be 4.83, and is likely to bioaccumalate. A bioconcentration factor of 2800 suggests the potential for bioconcentration in aquatic organisms is very high. But no data are available to indicate this phenomenon.

A Henry's Law Constant of 0.107 atm cu m/ mole will volatilize from most moist soil and may volatilize from dry soil. Adsorption to soil is expected to attenuate volatilization. Alphapinene is also expected to absorb to suspended solids and sediments in the water column based on the estimated K oc ( 1000). Volatilization half lives is estimated to be 4 hours in a model river and 5 days in a model lake. Rapid biodegradation of alpha pinene occurs in both soil and water based on a soil slurry study and screening studies.

beta pinene 1. Exists solely as a vapor in the ambient atmosphere and will be degraded by reaction with photochemically produced hydroxyl radicals ( half life for reaction: 4.9 hrs). 2. Not expected to directly photolyze due to the lack of absorption in the environmental UV spectrum.

1. Abiotic Degradation: Page 5 of 7 a. Hydrolysis: Not expected to occur due to the lack of hydrolyzable functional groups.

b. Photolysis: beta pinene not expected to directly photolyze due to the lack of absorption in the environmental UV spectrum.

2. Biotic Degradations:

a. Aqueous aerobic degradation: The biodegradation in aerobic waters is expected to be rapid based on studies performed on monoterpenes and alpha pinene.

b. Aqueous Anaerobic degradation: No literature studies are available.

c. Aerobic soil degradation: Pinene is degraded by microbiological organisms in soil.

Bioaccumulation: Log K ow of this chemical is estimated to be 4.35, and therefore is expected to bioaccumalate. A bioconcentration factor of 440 suggests some potential for bioconcentration in aquatic organisms.

A Henry's Law Constant of 0.160 atm cu m/ mole will volatilize from most moist soil and may volatilize from dry soil. Adsorption to soil is expected to attenuate volatilization. Betapinene is also expected to absorb to suspended solids and sediments in the water column based on the estimated K oc ( 1200). Volatilization half lives is estimated to be 1.2 hours in a model river and 4.6 days in a model lake. Rapid biodegradation of beta pinene occurs in both soil and water based studies performed on monoterpenes and alpha pinene.

Environmental Fate Data For alpha terpineol : Page 6 of 7 The following fate properties were obtained from an open literature search for alphaterpineol 1,2)

Environmental Fate Properties of alpha terpineol Alpha Terpineol Vapor Pressure @ 25o C ( mm Hg) 0.0423 Henry's Law Constant ( air/ water partition coefficient) ( atm cu m/ mole) 1.2 × 10 5 K OC ( organic carbon ratio in soil) 1000 Log K OW ( octanol/ water partition coefficient) 2.98 BCF 110 alpha terpineol 3. Exists solely as a vapor in the ambient atmosphere and will be degraded by reaction with photochemically produced hydroxyl radicals ( half life for reaction: 4 hrs). 4. Degraded in atmosphere by reaction with ozone ( half life for reaction: 40 minutes). 5. May also degrade in the atmosphere by reaction with nitrate radicals. 6. Not expected to directly photolyze due to the lack of absorption in the environmental UV spectrum.

1. Abiotic Degradation:

b. Hydrolysis: Not expected to occur due to the lack of hydrolyzable functional groups.

c. Photolysis: alpha terpineol not expected to directly photolyze due to the lack of absorption in the environmental UV spectrum.

2. Biotic Degradations:

a. Aqueous aerobic degradation: Ninety nine percent removal of alpha terpineol, at an initial concentration of 3.86 ppm, was incubated for 168  192 hours under aerobic conditions using sewage inoculum in a biological treatment study utilizing both batch and continuous digesters. In another study, alpha terpineol, at 4000 ppm, showed no biodegradation after about 23 days under aerobic conditions when added to 50 mL of mineral salts medium and 0.2 mL of radioactive waste trench leachate inoculum. Page 7 of 7 b. Aqueous Anaerobic degradation: No literature studies are available.

c. Aerobic soil degradation: Alph terpineol is readily biodegraded according to results from biological treatment simulation and a standardized screening test ( tests not specific to soil media)

Bioaccumulation: Log K ow of this chemical is estimated to be 2.98, and therefore has potential to moderately bioaccumalate. A bioconcentration factor of 110 suggests the potential for bioconcentration in aquatic organisms is moderate A Henry's Law Constant of 1.2 × 10 5 atm cu m/ mole will volatilize from most moist soil, but will not volatilize from dry soil. Alpha terpineol is also expected to absorb to suspended solids and sediments in the water column based on the estimated K oc ( 1000). Volatilization half lives is estimated to be 4 days in a model river and 32 days in a model lake. Rapid biodegradation of alpha terpineol should occur according to results from biological treatment simulation and a standardized screening test.

Surface and Ground Water Contamination:

Pine Oil is registered for indoor uses only and it is not likely to contaminate surface or ground water. In an event, however, if Pine oil is released to a waste stream, the three major constituents namely: alpha pinene, beta pinene and alpha terpineol volatilize rapidly from surface water, are highly biodegradable, they have short half lives in water, and have low mobility in soils. Hence there is low probability of surface and ground water contamination.

BIBLIOGRAPHY 1. Hazard Substances Databank ( HSDB), A Database of the National Library of Medicine's TOXNET System.

2. Environmental Fate Database. A Database of the Syracuse Research Corporation ( SRC).

References 1 and 2 use estimated fate parameters. In a number of cases, these parameters may be on the high end of estimation, a quantitative fate assessment is difficult to carry out.

3. Roy Erwin, National Park Service, Water Resource Division, Fort Collins, Colorado, July 1997


Email from Trent Doyle to Joe Nash on the 8(d) Lead Rule

02/05/2008 02:37 PM

	To

	Joseph Nash/DC/USEPA/US@EPA

	cc

	Subject

	Follow Up ? re TSCA 8(d) rule

Joe,

Per our conversation re the recent TSCA 8(d) final rule pertaining to lead in consumer products intended for children, please clarify whether the scope of the exclusion from reporting in 40 CFR 716.21(a)(8)(i)(A) for "children's metal jewelry" would cover components of such jewelry made of other materials, such as crystal or plastic.

Thanks,

Trent

Trent M. Doyle

tel:<PHONE_NUMBER>  |  fax:<PHONE_NUMBER>  |<EMAIL_ADDRESS> 1001 G Street, N.W., Suite 500 West  |  Washington, D.C. 20001

Keller and Heckman LLP

Serving Business through Law and Science®

Washington, D.C.  |   Brussels  |  San Francisco  |  Shanghai

Visit our websites at www.khlaw.com  or  www.packaginglaw.com for additional information on Keller and Heckman.

Mike Mattheisen/DC/USEPA/US

02/06/2008 09:15 AM

	To

<EMAIL_ADDRESS> 	cc

	Joseph Nash/DC/USEPA/US@EPA

	Subject

	Fw: Follow Up ? re TSCA 8(d) rule

EPA's TSCA 8d rule concerning the lead content of consumer products intended for use by children excludes children's metal jewelry as described by the Consumer Products Safety Commission in an ANPR it issued on Jan. 9, 2007 (72 FR 920).  73 FR 5112 (Jan. 29, 2008).    The ANPR concerns "children's metal jewelry containing more than 0.06% lead by weight in metal components."  EPA's 8d rule, therefore, does not exclude health and safety studies dealing with children's non-metal jewelry or non-metal components of metal jewelry.  In addition, CPSC ANPR explains why the ANPR was specific to children's metal jewelry:

Investigations by the CPSC Laboratory staff indicated that the extractability of lead from children’s metal jewelry is strongly associated with the lead content of these items. (920)

At this time, CPSC staff is focusing on metal jewelry containing lead because the available data indicate that such products could be hazardous due to their lead content and potential for exposure. More information concerning potential lead exposure of other non-metal materials that may be used in jewelry is needed before staff can assess whether other non-metal materials used in jewelry present a hazard. (921)

Mike Mattheisen

Acting Branch Chief

Chemical Information and Testing Branch

Chemical Control Division

US EPA Office of Pollution Prevention and Toxics

202-564-3077