  SEQ CHAPTER \h \r 1 U. S. ENVIRONMENTAL PROTECTION AGENCY

Washington, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

						             PC Code: 128974

                               DP 344482

                                       November 30, 2009

MEMORANDUM

DATE:         November 30, 2009

SUBJECT:   Completion of an aquatic acute toxicity study analyzing the
acute toxicity effects of

                     Quinclorac on the swimming ability of the
freshwater invertebrate Daphnia magna

FROM:         Lewis Ross Brown, Environmental Biologist

                     Brian Anderson, RAPL Team Leader

                     Nancy Andrews, Branch Chief

                     Environmental Risk Branch I

                     Environmental Fate and Effects Division (7507P)

TO:               Robert McNally, Risk Manager

                       Joy Schnackenbeck, Risk Reviewer

                     Pesticide Re-evaluation Division (7509P)

EFED-ERB 1 has completed the review and analysis of an aquatic acute
toxicity study exposing the freshwater invertebrate, known as the
Daphnia magna, to Quinclorac in order to analyzing the effects on
swimming ability of this organism. Below is short tabulation of our
findings:

MRID # 474210-01-“Quinclorac – Determination of the Acute Effect on
the Swimming Ability of the Water Flea Daphnia magna STRAUS”.-This
study is scientifically sound and meets the guideline requirements for
an acute toxicity study with freshwater invertebrates. The 48-hour EC50,
based on the sum of immobile daphnids, was >100 mg ai/L. The NOAEC was
100 mg ai/L. According to the results of this study, Quinclorac is
classified as practically non-toxic (based on the EC50 of the active
ingredient, >100 mg ai/L) to Daphnia magna on an acute toxicity basis,
in accordance with the classification system of the U.S. EPA.  This
study is categorized as “Acceptable”.

Results Synopsis:

Test Organism Age (e.g., 1st instar): neonates (2-24 hours)

Test Type (Flow-through, Static, Static Renewal): Static

EC50: >100 mg ai/L				95% C.I.: N/A

NOAEC: 100 mg ai/L

Probit Slope:	N/A				95% C.I.: N/A

Endpoint(s) Affected:  None

Please contact Lewis Ross Brown at<PHONE_NUMBER> with any questions or
comments.

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SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY 40 CFR PART 63, SUBPART JJ  NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS; FINAL STANDARDS FOR HAZARDOUS AIR POLLUTANT EMISSIONS FROM WOOD FURNITURE MANUFACTURING OPERATIONS 1. Identification of the Information Collection 1( a) Title of the Information Collection 40 CFR Part 63, Subpart JJ  National Emission Standards for Hazardous Air Pollutants; Final Standards for Hazardous Air Pollutants From Wood Furniture Manufacturing Operations.

1( b) Short Characterization/ Abstract The Final Standards for Hazardous Air Pollutants From Wood Furniture Manufacturing Operations were proposed on December 6, 1994, and promulgated on December 7, 1996. These standards apply to both existing wood furniture manufacturing operations and to new wood furniture manufacturing operations commencing construction, modification or reconstruction after the date of proposal that are major sources of hazardous air pollutants ( HAPs). This information is being collected to assure compliance with 40 CFR Part 63, Subpart JJ.

Owners or operators of the affected facilities described must make one time only notifications including: notification of any physical or operational change to an existing facility which may increase the regulated pollutant emission rate, notification of the initial performance test; including information necessary to determine the conditions of the performance test, and performance test measurements and results; notification of demonstration of the continuous monitoring system ( CMS). Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. Monitoring requirements specific to 40 CFR 63, Subpart JJ, provide information on compliance with the rule. Semiannual reports of excess emissions are required. These notifications, reports and records are required, in general, of all sources subject to 40 CFR Part 63.

Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records. All sources subject to general provisions of Part 63 are required to retain records for five years [ 40 CFR 63.10( b)( 1)].

Approximately 750 sources are currently subject to the standard, and based on information provided by the American Furniture Manufacturers Association, it is anticipated that no new facilities will come on line over the next three years. It is assumed that there is an average of one 2 affected facility per plant. The estimated recordkeeping and reporting costs of this ICR will be $ 4,999,151.

All reports are sent to the delegated State or local authority. In the event that there is no such delegated authority, the reports are sent directly to the EPA Regional Office.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants. These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction:

In addition, Section 114( a) states that:

. . . the Administrator may require any owner or operator subject to any requirement of this Act to ( A) establish and maintain such records, ( B) make such reports, ( C) install, use, and maintain such monitoring equipment or methods ( in accordance with such methods at such locations, at such intervals, and in such manner as the Administrator shall prescribe), and ( D) sample such emissions, ( E) Keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical, ( F) submit compliance certifications, and ( G) provide such other information as he may reasonably require.

In the Administrator's judgment, hazardous emissions from wood furniture manufacturers cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, a rule requiring wood furniture manufactures to control air emissions using maximum achievable control technology ( MACT) was promulgated for this source category at 40 CFR Part 63, Subpart JJ.

2( b) Practical Utility/ Users of the Data The control of emissions of hazardous air pollutant emissions from wood furniture manufacturing operations requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of hazardous air pollutants ( HAPs) from wood furniture manufacturers are the result of the operation of the affected facilities. These standards rely on the reduction of hazardous air pollutants by either the use of compliant or low HAP content coatings, use of control devices or some combination of these three control technologies. 3 The required notifications are used to inform the Agency or delegated authority when a source becomes subject to the standard. The reviewing authority may then inspect the source to check if compliant or low HAP coatings are actually being used and whether any pollution control devices installed are functioning properly. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standard, and note the operating conditions under which compliance was achieved. Semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by this rule continue achieve continuous compliance as required by the Clean Air Act.

The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria 3( a) Nonduplication The recordkeeping and reporting requested is required under 40 CFR Part 63, Subpart JJ. If the rule has not been delegated to a State Agency, the information is sent to the appropriate EPA Regional Office. Otherwise, the information is sent directly to the delegated State or Local Agency. If a State or Local Agency has adopted their own similar regulation to implement this rule, a copy of the report submitted to the State or local agency can be sent to the Administrator in lieu of the report required by the Federal Standard. Therefore, no duplication exists.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on August 17, 2000 ( FR 50196).

3( c) Consultations No comments were received on the burden published in the Federal Register.

Additional consultations concerning the industry growth rate over the next three years, and the burden costs of recordkeeping and reporting under the rule were conducted with the leading trade associations representing the industry, and the USEPA Office of Air Quality Planning and Standards. The contacts were: 1) The American Furniture Manufacturing Association, Mr. Larry Runyan, ( 336) 884 5000, 2) The Kitchen Cabinet Manufacturers Association, Mr. Richard Titus, ( 703) 264 1690, 3) The Business and Institutional Furniture Manufacturing Association, Mr. Brad Miller, ( 616) 285 3963, and 4) the Office of Air Quality and Planning ( EPA), Mr. Paul Almodovar, ( 919) 541 0283. 4 The industry representatives indicated that no net growth in the industry was expected over the next three years. They cited foreign competition as the main cause.

This rule was developed using the regulatory negotiation process. The industry participated in the rulemaking process and agreed to comply with the final rule, so they have a good understanding of the recordkeeping and reporting burden. They did not mention any specific problems with the rule burden during the consultations.

3( d) Effects of Less Frequent Collection If the information required by these standards was collected less frequently, the main consequence would be that the chances of detecting poor operation and maintenance of control equipment would decrease and some manufacturers would use noncompliant coatings or high HAP coatings. Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the required standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met.

3( e) General Guidelines None of the reporting or recordkeeping requirements contained in 40 CFR Part 63 or otherwise pertinent to this request violate any of the regulations established by OMB in 5 CFR 1320.6.

3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However, any information submitted to the agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contained in 40 CFR Part 63 or otherwise pertinent to this request contain sensitive questions. 5 4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents of the recordkeeping and reporting requirements are wood furniture manufacturers under the following SIC codes:

2434  Wood Kitchen Cabinets 2511  Wood Household Furniture, Except Upholstered 2512  Wood Household Furniture, Upholstered 2517  Wood Television, Radio, Photograph, and Sewing Machine Cabinets 2519  Household Furniture, Not Elsewhere Classified 2521  Wood Office Furniture 2531  Public Building and Related Furniture 2541  Wood Office and Store Fixtures, Partitions, Shelving, and Lockers 2599  Furniture and Fixtures, Not Elsewhere Classified 5712  Furniture Stores All affected facilities are located at plant sites that are major sources as defined in 40 CFR 63.2.

4( b) INFORMATION REQUESTED All the recordkeeping and reporting requirements in this ICR are required by 40 CFR Part 63, Subpart JJ. There have been no changes in regulatory requirements since the last ICR.

It should be noted that this rule requires affected facilities to maintain all records, including reports and notifications for at least 5 years. This is consistent with the General Provision to the rule. Furthermore, EPA believes that the 5 year records retention requirement is consistent the Part 70 permit program and the 5 year statute of limitations on which the permit program is based. Also, the retention of records for 5 years would allow EPA to establish a source's history and patterns of compliance for purposes of determining the appropriate level of enforcement action. Historically, EPA has found that the most flagrant violators frequently have violations extending beyond the 5 year statute of limitations. Therefore, EPA should be prevented from pursuing the worst violators due to the destruction or nonexistence of records if less than 5 years of records were kept.

Recordkeeping  5 year retention of records [ 63.806( j), 63.10( b)( 1)]  Records of startup, shutdown, or malfunction and corrective actions [ 63.806( a), 63.6( e) and 63.10( b)( 2)]  Records required as part of work practice standards implementation plan [ 63.806( e), 63.10( b)( 2)] 6  Records of CMS data [ 63.806( a), 63.10( b)( 2), 63.10( c), 63.6( e)]  CMS quality control program [ 63.807( a), 63.8( d)]  Records of types & quantities of finishing and cleaning materials and adhesives used, including VHAP and solids content data [ 63.806( b), 63.10( b)( 2)]  Records of monthly weighted average emission calculations [ 63.806( c), 63.10( b)( 2)]  Records of applicability determination/ area source status [ 63.806( a), 63.10( b)( 3)]  Records of performance tests and CMS performance evaluations [ 63.806( a), 63.10( b)( 2)]

Reports  Application for approval of construction/ reconstruction [ 63.807( a), 63.5( d)]  Notification of start up, construction, reconstruction, or modification [ 63.807( a), 63.5( b)( 4) and 63.9( b)]  Start up, shutdown, and malfunction plan and reports [ 63.807( a), 63.6( e)( 3) and 63.10( d)( 5)]  Notification of physical/ operational changes [ 63.807( a), 63.5( b)( 6)]  Site specific performance test and CMS performance evaluation test plans [ 63.807( a) 63.7( c) and 63.8( e)]  Notification and report of performance tests and results [ 63.807( a), 63.7( b) and ( g), 63.9( e), and 63.10( d)( 2)]  Notification and report of CMS performance evaluation and results [ 63.807( a) 63.8( e)( 2), 63.9( g), and 63.10( e)( 2)]  Semiannual compliance report [ 63.807( c), overrides 63.10( e)]  Work practice standards implementation plan [ 63.806( e), 63.10( d)( 1)]  Notification of applicability [ 63.807( a), 63.9( b)]  Notification and report of compliance status [ 63.807( b), 63.9( h)]

Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records. All sources subject to general provisions of Part 63 are required to retain records for five years [ 40 CFR 63.10( b)( 1)].

Respondent's Activities  Read instructions  Install, calibrate, maintain, and operate CMS  Perform initial performance test, Reference Methods 24 and 311, and repeat performance tests, as necessary.  Write the notifications and reports listed above  Enter information required to be recorded above  Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information. 7  Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.  Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and providing information.  Adjust existing internal procedures to comply with any applicable instructions and requirements  Train personnel to collect information  Transmit, or otherwise disclose the required information None of respondent activities listed above are considered " customary and usual business practices."

Various automated, mechanical or other technical collection techniques would typically be used to collect information at the plant site by the respondent to provide information to the Agency. The respondents would then mail various reports to the Agency. Reporting by the respondent is not frequent enough to warrant development of special direct transmission techniques ( i. e., electronic information exchange) between the respondent and the Agency. The Agency currently has no plans to develop such a system. All of the costs associated with the transmission of reports to the Agency have been include in the cost figures developed in Table 2, Annual Respondent Burden and Cost of Reporting and Recordkeeping Requirements for 40 CFR. 63, Subpart JJ.

5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the information required under 40 CFR Part 63, Subpart JJ:

 Observes initial and repeat performance tests  Reviews notifications and reports, including excess emissions reports, required to be submitted by industry.  Audits facility records  Compiles data in the AIRS database 5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to check if the pollution control devices are properly installed and operated. Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard, and note the operating conditions under which compliance was achieved. Data obtained 8 during periodic visits by Agency personnel from records maintained by the respondents are tabulated and published for internal Agency use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) which is operated and maintained by EPA's Office of Air Quality Planning and Standards. The AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses AFS for tracking air pollution compliance and enforcement by local and State regulatory agencies, EPA Regional Offices and Headquarters. EPA can edit, store, retrieve and analyze the data via PC terminals.

The records required by this rule must be retained by the owner or operator for five years.

5( c) Small Entity Flexibility Because of the large number of small businesses in the wood furniture industry, some of which will be impacted by the regulation, the impacts of the reporting and recordkeeping requirements on small businesses were considered carefully. The Small Business Administration ( SBA) definition of a small business wood furniture manufacturing facility is 500 or fewer employees. The majority of the approximately 11,000 wood furniture manufacturing facilities are expected to employee less than 500 people; however, only about 7 percent ( 750) of the existing 11,000 wood furniture facilities are expected to be major sources and thus subject to the rule. The rule for wood furniture manufacturing operations was developed using a regulatory negotiation approach. Small businesses were represented on the regulatory negotiation committee by the Architectural Woodwork Institute, a trade association consisting primarily of small businesses, and by Pridgen Cabinet Works and Stylecraft Corporation, two small wood furniture manufacturers. In addition, a small business Work Group was formed to specifically address issues relevant to small businesses.

One objective of the regulatory negotiation committee regarding reporting and recordkeeping requirements was to ensure that the proposed requirements were not beyond the resources of small businesses. For example, to decrease the burden on small businesses, semiannual rather than quarterly reporting is required. In addition, the regulation allows an additional year for smaller facilities that emit less than 50 tons per year of HAP to comply with the standard. The compliance date for these smaller facilities is 3 years after promulgation. Other reporting requirements also have been critically reviewed and determined to be the minimum necessary for enforcement agencies to ascertain compliance with the standards. An economic analysis also has been performed; the results of the analysis show that small business impacts are minimal. 9 Another provision of the rule that has been added to decrease the burden on small businesses addresses applicability of the standard. The rule is not applicable to sources that commit to using less than or equal to 250 gallons per month of coating, gluing, cleaning, and washoff materials, including materials used for source categories other than wood furniture. Owners or operators of these facilities would be required to maintain records of the total gallons of coating, gluing, cleaning, and washoff materials used each month but would not be subject to other provisions of the rule. Sources with actual emissions no more than 5 tons of any one HAP per year or 12.5 tons of a combination of HAP are also exempt from the standard. These exemptions are built into the rule and serve to minimize the number of small businesses subject to the rule.

5( d) Collection Schedule The compliance date for existing affected sources that emit less than 50 tons of HAP in 1996, was December 7, 1998. The compliance date for existing affected sources that emit 50 tons or more of HAP in 1996 was November 21, 1997. New wood furniture manufacturing operations will have to comply immediately upon startup. The standards require semiannual reporting. A more detailed schedule for the collection of information and publication of data is not applicable because reports and recordkeeping are triggered by action of the respondent.

6. Estimating the Burden and Cost of the Collection Table 2, Annual Respondent Burden and Cost of Reporting and Recordkeeping Requirements for 40 CFR. 63, Subpart JJ, documents the computation of burden for each recordkeeping and reporting requirement applicable to the industry. Each burden is expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. The methods of information collection for this rule are consistent and compatible, to the maximum extent practicable, with the respondents existing reporting or recordkeeping practices. Responses to this information collection are mandatory under 40 CFR Part 63, Subpart JJ.

The 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.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated at 80,062 technical person hours per year; 4,003 managerial person hours per year; 8,006 clerical person hours per year. These hours are based on Agency studies and background documents from the development of the standards and test methods, Agency knowledge and experience with the rule, the previously approved ICR, and any comments received about the costs to conduct recordkeeping and prepare reports. 10 6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses labor rates listed below. These labor rates are from the United States Department of Commerce Bureau of Labor Statistics Employment Costs for Civilian Workers by Occupational and Industry Group. .  Managerial: $ 78.10 ($ 37.19 per hour + 110% overhead)  Technical: $ 54.92 ($ 26.15 per hour + 110% overhead)  Clerical: $ 36.16 ($ 17.22 per hour + 110% overhead)

( ii) Estimating Capital and Operations and Maintenance Costs The type of industry costs associated with the information collection activity required by this rule are continuing O& M [( i. e., operation and maintenance of continuous monitoring systems ( CMS)] activities. There are no capital CMS start up costs for this ICR renewal because no new sources are expected to come on line during the next three years ( source: American Furniture Manufacturers Association). Since CMS are required only for sources selecting the control device compliance option, an estimated 10% of the sources will be using CMS. The O& M cost for each CMS is estimated to be $ 540 per year as reported by the Office of Air Quality Planning and Standards, US EPA. Therefore, the annual O& M costs are $ 40,500 per year ( 750 x 10% x $ 540).

( iii) Capital/ Start up vs. Operating and Maintenance ( O& M) Costs No new sources are expected to come on line during the next three years; therefore, the capital/ start up costs are zero and the annual operating and maintenance costs are same as above, $ 40,500.

( iv) Annualized Capital/ Start up Costs No new sources are expected to come on line during the next three years; therefore, the annualized capital/ start up costs are zero.

6( c) Estimating Agency Burden and Cost The only Federal costs are user costs associated with analysis of the reported information. Publication and distribution of the information are part of the Aerometric Information Retrieval System ( AIRS) Facility Subsystem ( AFS) which is operated and maintained by the EPA's Office of Air Quality Planning and Standards. Examination of records to be maintained by the 11 respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The annual Federal Government costs during the next three years is estimated to be $ 368,599 year. Agency costs for managerial, technical and clerical person hours are computed as follows:

 Managerial: GS 13, Step 1, $ 45.71 ($ 28.57 per hour x 1.6 benefits multiplication factor)  Technical: GS 10, Step 3, $ 29.18 ($ 18.24 per hour x 1.6 benefits multiplication factor)  Clerical: GS 6, Step 1, $ 19.50 ($ 12.19 per hour x 1.6 benefits multiplication factor)

6( d) Estimating the Respondent Universe and Total Burden and Costs Table 1, Annual Burden and Cost for the Federal Government to Implement Reporting and Recordkeeping Requirements for 40 CFR 63, Subpart JJ; and Table 2, Annual Respondent Burden and Cost of Reporting and Recordkeeping Requirements for 40 CFR 63, Subpart JJ may be found at the end of this document.

6( e) Bottom Line Burden Hours And Cost Tables ( i) Respondent Tally The number of existing sources subject to 40 CFR Part 63, Subpart JJ is 750. As noted above, no new sources are expected to come on line during the next three years. The total annual labor costs over the next three years are 92,071 person hours per year, and the total annual capital and O& M costs are estimated to be $ 40,500. Details upon which this estimate is based appear in Table 2, Annual Respondent Burden and Cost of Reporting and Recordkeeping Requirements for 40 CFR 63, Subpart JJ, and the discussion above under items 6( b)( ii) and 6( b)( iii) .

( ii) The Agency Tally The annualized burden the Federal government is 9,664 person hours and $ 280,824 per year as shown on Table 1, Annual Burden and Cost for the Federal Government to Implement Reporting and Recordkeeping Requirements for 40 CFR 63, Subpart JJ.

( iii) Variations In The Annual Bottom Line No significant ( i. e, over 25%) variations in the annual bottom line are expected over the next three years. 12 6( f) Reasons for Change in Burden A small decrease in burden to the Federal government and a small increase in burden to the industry occurs in this ICR compared to the previous ICR primarily because of an changes in the overall labor rates for both the Federal government and industry. It should be noted that all initial one time only activities to achieve initial compliance were completed during the previous ICR approval period; therefore, no initial one time only activities do not appear in this ICR.

Table 1, Annual Burden and Cost for the Federal Government to Implement Reporting and Recordkeeping Requirements for 40 CFR Part 63, Subpart JJ, shows a decrease in the overall cost. This due to a reduction in the overhead rate from 110% in the previous ICR to 60% ( i. e., the 1.6 benefits multiplication factor) in this ICR. The 1.6 factor reflects the true cost to the Federal government to employ a Federal worker. The new labor rate for each of the three person hour categories is as follows: managerial at $ 45.71 vs. $ 52.67 per hour, technical at $ 29.18 vs. $ 35.87 per hour, and clerical at $ 19.50 vs. $ 22.47 per hour.

Table 2, Annual Respondent Burden and Cost of Reporting and Recordkeeping Requirements for 40 CFR 63, Subpart JJ, shows a small increase in the overall cost. This primarily due to an increase in the labor rates for each of the three person hour categories ( i. e., managerial at $ 78.10 vs. $ 50.48 per hour, technical at $ 54.92 vs. $ 35.89 per hour, and clerical at $ 36.16 vs. $ 23.07 per hour). An Increase in estimated annual burden hours was because of 10 additional respondents per year, thus increasing the total from 88 to 98.

6( g) Burden Statement The total annual burden for recordkeeping and reporting requirements under this rule is 92,071 hours. The total number of annual responses is 47,800. The average annual burden per response is therefore 1.92 hours. The estimated cost to the respondents is $ 40,500 based on an estimated 750 respondents.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to 13 the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


HAZARDOUS WASTE DETERMINATION REQUIREMENTS

      There are no Agency activities associated directly with generator waste determinations.  EPA may review results of such determinations during site inspections.

      LARGE QUANTITY GENERATOR PRE-TRANSPORT REQUIREMENTS

      Although personnel training information is not formally submitted to EPA, EPA may review information collected from the requirements during facility inspections.  Therefore, this analysis assumes that the Agency will spend a minimal amount of review time at certain facilities.

       Agency activities associated with emergency reporting requirements include reviewing documents in the emergency coordinators' emergency reports.

      Agency activities associated with the receipt of reports of releases are review of the information submitted, entry of this information into a database tracking all releases, and, if necessary, transmittal of the information to the respective emergency response authorities.                     Agency activities associated with requirements for generators' tank systems include the following:

 Review and evaluate information on equivalent containment devices;

 Evaluate information submitted for exemption from the 24-hour leak detection requirement; and

 Evaluate information submitted for variances from secondary containment requirements, including no-free liquids demonstrations.

      In addition, the Agency must perform the following activities for generators' tank systems:

 Evaluate information submitted for exemption from 24-hour waste removal requirement;

 Review existing tank integrity assessments;

 Review new tank design and installation assessments;

 Review release notification reports;

 Review major repair certifications; and

 Review requests for accumulation period extensions.

      Agency activities associated with requirements for generators' drip pads include the following:

 Review plans for upgrading drip pads;

 Review and evaluate drawings and certifications of drip pads;

 Evaluate notices of releases from drip pads; and

 Review repairs conducted to drip pads.

      Agency activities associated with requirements for generators' containment buildings include the following:

 Review and evaluate notifications of releases of hazardous waste; and

 Review notices of repairs to containment buildings.

      Some of the records and certifications required under this section are not formally submitted to EPA, but must be kept on file at the facility and made available to EPA upon request.  On others, the regulations are not explicit about whether a demonstration must be submitted to EPA; this ICR generally assumes that LQGs submit the demonstrations anyway.

      LARGE QUANTITY GENERATOR AIR EMISSION STANDARDS

      (1)	Air Emissions from Process Vents

      There are no Agency activities associated with the requirements for generators with process vents.  Although EPA will examine monitoring documentation, control device documentation, waste determination documentation, and information required in the operating record during periodic inspections, these activities are part of EPA's overall compliance and enforcement program.  Therefore, the cost associated with these activities is not attributable to subpart AA.

      (2)	Air Emissions from Equipment Leaks

      Agency activities associated with the requirements for generators with equipment subject to subpart BB include:

 Reviewing notifications to implement the alternate valve standard specified in section 265.1061(a));  Reviewing notifications to discontinue implementing the alternate valve specified in section 265.1061(a)); and

 Reviewing notifications to implement the alternate valve standard specified in sections 265.1062(b)(2) or (b)(3)).

      SMALL QUANTITY GENERATOR PRE-TRANSPORT REQUIREMENTS

      The Agency activities associated with SQG pre-transport requirements include reviewing requests for extensions of the accumulation period under section 262.34(e).  No other information is required to be submitted to EPA (SQG notification requirements include contacting the National Response Center, operated by the Coast Guard).                RECORDKEEPING AND REPORTING

      Agency activities associated with the recordkeeping and reporting requirements include the on-site review of documents maintained at a facility, and the review of submitted information and the entry of this information into a database.

      EXPORT AND IMPORT REQUIREMENTS

      Agency activities associated with the receipt of notifications and re-notifications of intent to export hazardous waste involve the review of this information, and to submit, in conjunction with the Department of State, a notification to the receiving country and any transit countries.  Upon the consent (or refusal) of the receiving  countries to the receipt of the hazardous waste, the Agency will forward to the primary exporter an acknowledgment of consent (or a written notification of the objection).  Other Agency activities associated with the export of hazardous waste are the receipt of Annual Reports.  The Agency will review these documents and enter them into a database.  During compliance inspections, the Agency will also review records kept on site.

      The OECD Decision requires the Agency to perform the following additional information collection and management activities.  These activities are in addition to the baseline (non-OECD) information collection and management requirements already imposed by RCRA for hazardous waste exports and imports.

Exports from the U.S.:     Receive and record the Acknowledgment of Receipt from the importing country

 Receive and record the Tracking Document received from the foreign recovery facility.    Imports to the U.S.:

 Transmit an Acknowledgment of Receipt to the foreign exporter, competent authority of the foreign exporting country, and competent authority of transit country(ies) if applicable

 Receive and record the Tracking Document received from the U.S. recovery facility.

      5(b)	COLLECTION METHODOLOGY AND MANAGEMENT

      In collecting and analyzing the information required under the generator requirements, EPA uses personal computers and applicable database software, when appropriate.

      5(c)	SMALL ENTITY FLEXIBILITY

      When promulgating the regulations covered under this ICR, EPA considered the effect of these regulations on small businesses.  EPA found, however, that most small businesses do not generate hazardous waste and, therefore, are not significantly affected by the generator standards. EPA has been directed by Congress to promulgate standards to protect public health and the environment.  In certain cases, such as the Annual Report requirements for primary exporters of hazardous waste, EPA has limited the informational requirements for small generators.  These facilities do not have to include a description of efforts taken to reduce waste volume or toxicity, or descriptions of any variation in the volume and toxicity of wastes relative to previous years.  Certain categories of small entities are exempt from the information collection requirements described herein.  Others are subject to reduced requirements.  The training requirements do not apply to small quantity generators.  Nor are they subject to the contingency plan and emergency procedure requirements.  Finally, such generators are subject to reduced tank standards under section 265.201.

      5(d)	COLLECTION SCHEDULE

      HAZARDOUS WASTE DETERMINATION REQUIREMENTS

      There is no collection schedule for generators' hazardous waste determinations.

      PRE-TRANSPORT REQUIREMENTS (FOR BOTH LQGs AND SQGs)

      The reporting requirements outlined in the regulations will vary according to individual facility circumstances.  Because container labeling and keeping records of personnel training are conducted onsite, a discussion of a collection schedule is not relevant.

      There is no collection schedule for generators reporting releases of hazardous waste into the environment, as facilities only report on these occasions. The emergency coordinator must immediately notify the appropriate authorities of an imminent or actual emergency situation.  An LQG must submit a written report of any incident that requires the implementation of the contingency plan within 15 days of its occurrence.  Since generators are not required to submit their contingency plans to EPA, discussion of a collection schedule for these facilities is not applicable.

      Records of tank system assessments, statements on design and installation, and records of annual leak tests and inspections are kept by the LQGs.  Therefore, a discussion of a collection schedule is not applicable.  The time frame for submitting demonstrations provided under this section is dependent upon the desire of LQGs to submit such demonstrations.  However, the regulations do specify time frames for submissions related to certain situations.  LQGs must submit release notification reports within 30 days of detecting a release.  In addition, the certification of major repairs (required under §265.196(f)) must be submitted within seven days of returning the repaired tank system to use.  With regard to drip pads, plans for upgrading drip pads must be prepared 2 years before completion of such repairs, pad assessments must be recertified annually, records of releases must be documented upon detection and notice provided to EPA within 24 hours (written notice in within 10 days), and notice of repairs provided upon completion of such repairs.  As for containment buildings, certification that the building meets design requirements is required within 60 days of initiating operation, records of releases must be filed upon detection and notice to EPA provided within 7 days (written notice within 14 days).  In addition, monitoring data must be placed in the record every 7 days.

      There is no collection schedule for generators requesting extensions from the Regional Administrator of the accumulation period, as these requests presume unforeseen circumstances.

      LARGE QUANTITY GENERATOR AIR EMISSION STANDARDS

      The regulations at 40 CFR part 265, subparts AA and BB for generators do not specify time frames for submittals, and a discussion of a schedule regarding these requirements is not applicable.              RECORDKEEPING AND REPORTING

      As the recordkeeping regulations in section 262.40 do not require the transmittal of any information, a discussion of a schedule regarding this requirement is not applicable.  Additionally, as section 262.43 allows the Administrator to require additional information of generators on an irregular basis, a discussion of a collection schedule is not applicable.

      EXPORT REQUIREMENTS

      Generators meeting the definition of primary exporters should notify the EPA 60 days before the initial shipment of waste is scheduled to leave the United States (§262.53).  The notifications of intent to export are collected as necessitated by generator activities.  EPA has limited the burden of collection by allowing one notification to cover activities extending over a twelve-month period, unless certain conditions are altered.

      Under the rule codifying the OECD Decision, Notification of Intent to Export submissions and tracking documents are generated and sent to EPA on a random, occurrence-specific basis for which there is no formalized schedule.  Once these events do occur, notifications must be sent to EPA within 45 days prior to initiating waste exports, and tracking documents must be sent to EPA by U.S. recovery facilities within three working days of receipt of imported wastes.

      The collection schedule for export activity Annual Reports requires their submittal no later than March 1 of the following year (§262.56).  The report must include information regarding the primary exporter, transporter, and consignee, as well as the volume and characteristics of the waste.   The report must also include a description of any variation in the volume and toxicity of wastes relative to previous years (not applicable to generators of more than 100 kilograms but less than 1000 kilograms of hazardous waste in a calendar month or to those already submitting information in the Biennial Report), and a signed certification.  The recordkeeping regulations in section 262.57 do not require the transmittal of any information; a discussion of a schedule regarding this requirement is not applicable.        6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

      6(a)	ESTIMATING ANNUAL RESPONDENT BURDEN

      This ICR is a comprehensive presentation of all of the information collection activities required for generator standards and covers Fiscal Years 2011-2013.

      Exhibit 1 summarizes the universe of generators.  EPA estimated respondent burden hours and costs associated with all of the requirements covered in this ICR in the following exhibits: Exhibit 2 addresses both LQG and SQG respondent burden for reading the regulations; Exhibit 3 addresses LQG pre-transport requirements; Exhibit 4 addresses LQG air emission standards; Exhibit 5 addresses SQG pre-transport requirements; Exhibit 6 and 7 address specific export and import requirements for all generators; and Exhibit 8 summarizes total annual aggregate respondent burden and costs for all activities.

      6(b)	ESTIMATING ANNUAL RESPONDENT COSTS

      Exhibits 2 through 8 estimate the costs to generators based on the cost of labor, operation and maintenance (O&M), and capital.  For purposes of this analysis, EPA estimates an average hourly respondent labor cost (including fringe and overhead) of $120.92 for legal staff, $71.48 for managerial staff, $53.25 for technical staff, and $32.03 for clerical staff. These wage rates were used in the recently developed ICR renewal for the Land Disposal Restriction requirements. (See ICR No. 1442, OMB control number is 2050-0085).  In turn, these rates are based on actual Bureau of Labor Statistics (BLS) mean rates, plus overhead and fringe benefits.

      In the following paragraphs, EPA estimates capital costs associated with the information requirements covered by this ICR.  Capital costs usually include any produced physical good needed to provide the needed information, such as machinery, computers, and other equipment.  For this ICR, the only required capital is file cabinets for maintaining reports.  As shown in Exhibit 9, EPA estimates the total average annual capital cost to all generators, collectively, to be approximately $24,881.

 Estimate the total annual volume of reports required to be retained by all generators.  In total, EPA estimates that LQGs must maintain approximately 91 pages of reports annually, while SQGs maintain approximately 2 pages.  Ascertain the number of standard-size file cabinets that would provide the needed capacity and estimate the aggregate purchasing price.  Given that a standard-size, five-drawer, lateral file cabinet holds approximately 16,000 pages, EPA estimates that the hazardous waste industry would need to purchase approximately 91 file cabinets each year (i.e.,1,456,000/16,000).  These 91 file cabinets represent the total capacity needed by the industry, collectively, to store all of its reports.  EPA estimates that the purchasing price for one file cabinet is $870, and for all 91 file cabinets, $79,170.         Annualize the aggregate purchasing price using a net present value formula.  EPA used the following annualized net present value formula to calculate the annual cost to the hazardous waste industry to acquire these file cabinets:                          Annual Cost = $70,474(A/P, k, t)

            where 	A/P = capital recovery factor;             		k = discount rate of 7 percent;             		t = life of equipment (3 years).

            Based on this formula, the total annualized cost of file cabinets was reported in ICR 0820.10 to be approximately $26,851.

 	For this ICR, because the estimated cost of one file cabinet was confirmed to be the same as in previous years, the total costs were estimated by using a percentage of the previous total based on the decrease in the universe of respondents.

      O&M costs are those costs associated with a paperwork requirement incurred continually over the life of the ICR.  They are defined by the PRA as "the recurring dollar amount of cost associated with O&M or purchasing services."  For this ICR, O&M costs cover postage and an envelope for reports sent to other parties $1.56 postage, 4 cents per standard envelope) photocopying of reports submitted to the Agency (11 cents per page), for long-distance phone calls ($5.00 per call).  O&M costs are shown in Exhibits 2 though 9 for all applicable activities.

  	6(c)	ESTIMATING ANNUAL AGENCY BURDEN AND COST

      EPA estimates Agency burden hours and costs associated with all the requirements covered in this ICR in Exhibit 9.  EPA estimates an average hourly Agency labor cost of $58.46 for Regional legal staff, $54.88 for Regional managerial staff, $32.84 for Regional technical staff, and $20.95 for Regional clerical staff.  EPA used the 2010 Federal Pay Schedule salary figures to estimate annual compensation of Regional legal, managerial, technical, and clerical staff.  For purposes of this ICR, EPA assigned Regional staff the following government service levels:              Legal staff		GS-15, Step 1       Managerial staff	GS-13, Step 1       Technical staff		GS-11, Step 1       Clerical staff		GS-06, Step 1

      EPA divided annual compensation estimates by 2,080, the number of hours in a Federal work year, and multiplied the rates by the standard government overhead factor of 1.6 to derive hourly rates.                     6(d)	ESTIMATING THE RESPONDENT UNIVERSE

      LARGE QUANTITY GENERATOR AND SMALL QUANTITY GENERATOR REQUIREMENTS (Exhibits 1 and 2)

      (1)	Reading the Regulations

      Based on the 2009 Biennial Reporting System (BRS), which is the most currently available, EPA estimates that there are approximately 14,710 LQGs.   A number of these LQGs (322), however, are also hazardous waste treatment, storage, and disposal facilities (TSDFs).These facilities are covered by other ICRs and were deleted from facilities covered in this document, yielding an estimated 14,388 LQGs.               Based on its analysis of the 2010 RCRA INFO Data System, EPA estimates that there are approximately 74,958 small quantity generators (SQGs). This estimate is derived from those facilities who notified EPA or their authorized state on or after January 1, 2006 up until the present -or for the last five years. This estimate includes facilities that generated hazardous waste and managed it either on-site or off-site. This estimate may also include facilities that went out of business, or shifted regulatory status to either a conditionally exempt small quantity generator or to an LQG. EPA believes this number represents the higher end of the SQG universe.               An examination of the Waste Received (WR) Form for the 2009 Biennial Report identified an estimated 30,859 SQGs who transported their hazardous waste off-site using a hazardous waste manifest. EPA believes this is the lower end of the SQG universe. For purposes of this ICR renewal, EPA is providing a estimated range of between 30,859 and 74,958 SQGs.                 EPA also believes that a number of the LQGs (about 376) and SQGs (about 49) also are government-owned and government-operated facilities and, therefore, not addressed in this ICR.  Subsequently, these government-owned and government-operated generators were deleted from the universe covered in this ICR, yielding an estimated 14,012 LQGs, and at the high end 74,909 SQGs, and 30,810 SQGs at the low end.  As shown in Exhibit 1, approximately 88,921 generators comprise the high end of the respondent universe, and 44,822 the low end of the respondent universe.  As shown in Exhibit 2, EPA expects that each LQG will average one hour to read the generator standards once a year, while each SQG will average 42 minutes per year.                                           EXHIBIT 1                             UNIVERSE OF GENERATORS

                                                                      WASTE HANDLER TYPE

                                 Total number

                                      TSD

                                    Federal

                                                                   NUMBER OF WASTE HANDLERS

Large Quantity Generator 14,710 322 376                                                                          14,012

Small Quantity Generator

High end -74,958

49

                                                              High end - 74,909                                                              Low end  -  30,810 Total (High End)

                                                                         88,921 Total (Low End)

                                                                         44,822              HAZARDOUS WASTE DETERMINATION REQUIREMENTS (Exhibit 3)

	            Under 40 CFR 262.11, all generators must determine whether their solid waste qualifies as hazardous under RCRA.  Generators may test the waste or use knowledge of the waste to make this determination.

      EPA notes that generators must also determine, under the Land Disposal Restrictions (LDR) Program, whether their hazardous waste is restricted from land disposal, as required by 40 CFR 268.7(a)(1) and 268.9(a).  EPA has burdened generators for their LDR determinations in the Land Disposal Restrictions ICR, Number 1442.

      EPA has confirmed through consultations that generators normally make their hazardous waste and LDR determinations simultaneously and therefore do not incur a separate burden for each determination.  For example, a generator would normally make a single request to a laboratory to determine if its waste is both hazardous and restricted from land disposal.  Given this reasoning, EPA does not burden generators in this ICR for making hazardous waste determinations, since this burden is already reflected in ICR 1442.

      LARGE QUANTITY GENERATOR PRE-TRANSPORT REQUIREMENTS (Exhibit 3)

      (1)	Labeling

      In section 262.34(a)(2) and (3), EPA requires all LQGs to label containers with the words "Hazardous Waste" and the date of accumulation.  EPA expects that all LQGs to comply with this requirement.  In section 262.34 (c)(1) and (2), EPA requires LQGs accumulating hazardous waste at satellite accumulation areas to label containers as specified.  EPA expects that all LQGs will comply with these requirements each year.              (2)	Personnel Training

      In section 262.34(a)(4), EPA requires all LQGs to comply with the personnel training requirements in section 265.16(d).  Section 265.16(d) and (e) require that LQGs maintain copies of personnel training documents and records at their facilities.  Based on an examination of historical BRS data and trends, EPA estimates that about 22 percent, or 3,083 LQGs each year are new entrants into the hazardous waste universe and will be required to collect information regarding their employees' training experiences.

      (3)	Contingency Planning and Emergency Procedures

      This ICR assumes that existing LQGs have already prepared contingency plans.  Therefore, only new LQGs will be required to document whether State or local authorities decline to enter into an agreement to become familiar with the LQG's facility and its wastes, and to prepare and maintain a contingency plan.  EPA estimates LQGs will need to make copies of and send the plans to three local authorities, on average.  Amendments to contingency plans of LQGs must also be made when appropriate. EPA estimates that about 7 percent of the new LQG entrants, or 216 new LQGs will prepare original contingency plans annually, and that 10 percent of the LQG universe, or 1,401 LQGs will amend their contingency plan annually, during the period covered by this ICR.

      Based on Emergency Response and Notification System (ERNS) data, the Agency estimates that about 1.7 percent of all LQGs will have emergency incidents requiring implementation of the contingency plan.  Therefore, approximately 238 LQGs will be required to prepare emergency reports each year.         (4)	Tank Systems

      In section 262.34(a)(1), EPA requires all LQGs that accumulate hazardous waste in tanks for 90 days or less to comply with subpart J of part 265.  Of all 14,012 LQGs, EPA estimates that 75 percent use containers to accumulate hazardous waste, and the remaining 25 percent use tank systems.  The respondent universe for LQGs operating tank systems is 3,503 LQGs.              Depending on how the tank owner desires to comply with the regulations, he or she may need to submit one or more of the following:  a no-free-liquids demonstration (§265.190(a)), existing tank system assessments (§265.191), an equivalent containment exemption (§265.193(d)), a variance from secondary containment requirements (§265.193(g)), or annual leak tests and inspections (§265.193(i)).  Most LQGs seeking to operate under these conditions have already made the required demonstrations.  In general, only LQGs recently subjected to hazardous waste regulations will need to perform these demonstrations.    EPA estimates that approximately three percent or 105 respondents are subject to the leak tests and that one percent or 35 LQGs are subject to the other demonstration and testing requirements in sections 265.190 through 265.193.

      In addition, in certain circumstances (e.g., a new tank, a hazardous waste release, or a repair to a tank), LQGs must submit one or more of the following:  new tank system assessments and certifications (§265.192); an exemption from the 24-hour leak detection requirement (§265.193(e)(3)(iii)); or release notifications and reports, and major repair certifications (§265.196(d) and (f)).  As these are ongoing informational requirements, EPA estimates that:

   * Three percent or 105 LQGs will need to make new tank system assessments and certifications.  Of that number, approximately four (4) facilities will petition for an exemption from the 24-hour leak detection requirement; and

   * One percent or 35 LQGs will report a release or a major repair certification.  In addition,      approximately four (4) facilities will need to compile evidence of their inability to comply with the 24-hour waste removal requirement.

              (5)	Drip Pads

      Under section 262.34(a)(iii), EPA authorizes LQGs to store hazardous waste on drip pads for 90 days or less pursuant to part 265, subpart W.  Part 265, subpart W is primarily applicable to those facilities conducting wood preserving operations.  EPA expects that most existing wood preserving sites have already conducted the one-time activities (e.g., contingency planning, integrity assessments) required in part 265.  New entrants to the wood preserving industry, however, would be subject to these requirements.  Based on an analysis of 2009 BRS data, EPA expects that, each year, 9 new sites will be subject to these one-time requirements.  EPA further expects that 15 percent of facilities (1) will prepare a contingency plan for incidental drippage and will have a condition contributing to an actual release of hazardous waste and be subject to the recordkeeping, notification, repair and certification requirements.                  (6) 	Containment Buildings

      Under section 262.34(a)(iv), EPA authorizes LQGs to store hazardous waste in containment buildings for 90 days or less pursuant to part 265, subpart DD.  Part 265, subpart DD is potentially applicable to all large quantity hazardous waste generators.  EPA estimates that approximately 0.1 percent of the LQGs (14) use containment buildings.  EPA estimates that 25 percent of these affected facilities (4) will be subject to the recordkeeping and notice requirements associated with hazardous waste releases, and that all of these 14 facilities will require documentation to support compliance with subpart DD requirements.

      (7)	Requests for Extensions of the Accumulation Period

      EPA promulgated regulations in section 262.34(b) allowing LQGs to request extensions (up to 30 days) of the accumulation period limit from the Regional Administrator. EPA estimates that only one percent of all LQGs, approximately 140 LQGs, will request this extension each year.

      LARGE QUANTITY GENERATOR AIR EMISSION STANDARDS (Exhibit 4)

      (1)	Air Emissions from Process Vents

      EPA estimates that 1.5 percent of all LQGs, or 210 generators will be subject to 40 CFR part 265, subpart AA, in light of the applicability requirements of section 265.1030(b)(1)-(3). Of this estimate, approximately 50 percent, or 105 LQGs, will be subject to reassessing their implementation schedule, documentation with compliance, and performance plan, among other operating record requirements.

      (2)	Air Emissions from Equipment Leaks

      Based on an analysis of the 2009 BRS, as well as discussions with a sample of large quantity generator facilities, EPA estimates that up to 3,923 (or 28 percent) LQGs are subject to 40 CFR part 265, subpart BB requirements  -  depending on the specific paperwork burden category.

      (a)	Notification to implement the alternate valve standard specified in Section 265.1061(a)

      Based on previous experience, EPA estimates that 20 percent of generators subject to subpart BB will decide to implement the alternative standard specified in section 265.1061(a) each year. Therefore, 185 facilities will be required to prepare notification to implement the alternate valve standard specified in section 265.1061(a).

      (b)	Notification to discontinue implementing the alternative valve standard specified in Section 265.1061(a)              Based on previous experience, EPA estimates that 185 generators subject to subpart BB (i.e., 28 percent of the total affected universe) have implemented the alternative standard for valves specified in section 265.1061(a), and one percent of these generators will discontinue using the alternative standard each year.  Therefore, 2 generators will be required to prepare notification to discontinue implementing the alternate valve standard specified in section 265.1061(a).

      (c)	Notification to implement the alternative valve standard specified in Section 265.1062(b)(2), or (b)(3).

      Based on previous experience, EPA estimates that ten percent of generators subject to subpart BB will decide to implement the alternative standard specified in section 265.1062(b)(2) or (b)(3) each year.  Therefore, 392 generators will be required to prepare notification to implement the alternate valve standard specified in section 265.1062(b)(2) or (b)(3).

      (d)	Non-Hazardous Waste Documentation              Based on previous experience, EPA estimates that 10 percent of generators with equipment subject to subpart BB will use knowledge to determine that each piece of equipment does or does not contain hazardous waste with organic concentration that equals or exceeds 10 percent waste.  Therefore, approximately 392 facilities will be required to prepare non-hazardous waste documentation.

      (e)	Unit Operating Record

      All generators subject to subpart BB are required to maintain a unit operating record.  The contents of the operating record will vary according to site-specific circumstances.  A discussion of the respondent burden for each data item is presented below:

      (i)	Equipment Record

      This ICR assumes that generators with equipment subject to subpart BB have already prepared an equipment record.  EPA estimates that all generators (3,923) units will reassess, file, and maintain their equipment record, and 10 percent of this universe (approximately 392 units) will modify it annually.               (ii)	Implementation Schedule

      This ICR assumes that generators with equipment subject to subpart BB have already prepared an implementation schedule.  EPA estimates that all generators (3,923) will reassess, file, and maintain their implementation schedule, and 10 percent of this universe approximately 392 units) will modify it annually.

      (iii)	Performance Test Plan              This ICR assumes that generators using test data to demonstrate the organic removal efficiency or total organic compound concentration achieved by the control device have already prepared a performance test plan.  EPA estimates that all generators using test data to demonstrate the organic removal efficiency or total organic compound concentration achieved by the control device (approximately 3,923 facilities) will reassess, file, and maintain their performance test plan, and 10 percent (approximately 392 units) will modify it annually.              (iv)	Documentation of Compliance with Section 264.1060

      This ICR assumes that generators subject to subpart BB have already prepared a documentation of compliance.  EPA estimates that all generators (3,923 units) will reassess, file, and maintain their section 265.1060 compliance documentation, and 10 percent (approximately 392 units) will modify it annually.              (v)	Leak Inspection Log

      EPA estimates that all generators subject to subpart BB (3,923 units) may have equipment leaks during the period covered by this ICR.  Therefore, 3,923 will be required to prepare and maintain a leak inspection log.  All generators will be required to reassess and modify their inspection log.               (vi)	Design, Monitoring, Operation, and Inspection Information

      This ICR assumes that generators with equipment subject to subpart BB have already prepared design, monitoring, and inspection information for each closed-vent system and control device.  EPA estimates that all generators with closed-vent systems and control devices (approximately 3,923 units) will reassess, file, and maintain control device operation documentation, and 10 percent (approximately 392 units) will modify it annually.

      (vii)	Equipment Log

      This ICR assumes that generators with equipment subject to subpart BB have already prepared an equipment log.  EPA estimates that all generators (3,923 units) will reassess, file, and maintain their equipment log, and 10 percent (approximately 392 units) will modify it annually.

      (viii) Valve Log for Valves Subject to Section 265.1057(g) and (h)

      This ICR assumes that generators with valves subject to section 265.1057(g) and (h) have already prepared a valve log.  EPA estimates that all generators with valves subject to section 265.1057(g) and (h) (approximately 7 percent or 275 units) will reassess, file, and maintain their valve log, and 10 percent (approximately 28 units) will modify it annually.

      (ix)	Valve Log for Valves Subject to Section 265.1062              This ICR assumes that generators with valves subject to section 265.1062 have already prepared a valve log. EPA estimates that all generators with valves subject to section 265.1062 (approximately 3.5 percent of 275 or 56 units) will reassess, file, and maintain their valve log, and 10 percent (approximately 6 units) will modify it annually.

      (x)	Criteria Log              This ICR assumes that generators subject to subpart BB have already prepared a criteria log documenting information required in sections 265.1052(d)(5)(ii) and 265.1053(e)(2) for pumps in light liquid service and compressors.  EPA estimates that all generators with equipment subject to sections 265.1052(d)(5)(ii) and 265.1053(e)(2) (3,923 units) will reassess, file, and maintain their criteria log, and 10 percent (approximately 392 units) will modify it annually.        	        (xi)	Exemption Log

      This ICR assumes that generators potentially subject to subpart BB have already documented information determining applicability of subpart BB to their unit's equipment.  EPA estimates that all generators (3,923 units) will reassess, file, and maintain this documentation, and 10 percent (approximately 392 units) will modify it annually.              SMALL QUANTITY GENERATOR PRE-TRANSPORT REQUIREMENTS (Exhibit 5)

      (1)	Labeling

      This ICR assumes that all SQGs will need to label their containers and tanks in compliance with the section 262.34(a)(2) and (3) and section 262.34(c) requirements.

      (2)	Emergency Procedures

      EPA promulgated regulations in section 262.34 requiring SQGs to immediately notify the local fire department and/or National Response Center, as specified, for emergencies.  Based on recent ERNS data, EPA estimates that 1.7 percent of all SQGs (1,273) will report such an event each year.               (3)	Requests for Extensions of the Accumulation Period

      EPA promulgated regulations in section 262.34(f) allowing SQGs to request from the Regional Administrator extensions (up to 30 days) of the accumulation period limit.  EPA estimates that one tenth of one percent of all respondents, approximately 75 SQGs, will request an extension each year.                     RECORDKEEPING AND REPORTING REQUIREMENTS (Exhibit 6)              All generators (both LQGs and SQGs) must comply with the recordkeeping and reporting requirements detailed in sections 262.40 and .43.  This ICR does not burden generators for their hazardous waste determinations, since they are already burdened for recordkeeping of test results in the LDR ICR, Number 1442.  (Refer to the "Hazardous Waste Determination Requirements" in this section for further discussion on EPA's assumptions.)  EPA estimates that one tenth of one percent of all generators, approximately 89, will also be required to submit certain additional information (§262.43). Based on the ratio of LQGs to SQGs, EPA estimates that approximately 14 are LQGs and 75 are SQGs.

      EXPORT AND IMPORT REQUIREMENTS (Exhibits7 and 8)

      Based on export notifications tracked by EPA's Office of Enforcement and Compliance Assurance (OECA), EPA estimates that approximately 702 generators will export hazardous waste each year under 40 CFR 262.53, and .55 - .57, and will be required to notify EPA of their intention to export hazardous waste, file an Annual Report with the Administrator summarizing the types, quantities, frequencies, and ultimate destination of all hazardous wastes exported during the previous years, and keep copies of relevant documents for a period of three years. Data were not available for generators re-notifying under 40 CFR 262.54(g).  We therefore pro-rated 2007 notification to re-notification data to derive an estimate of 45 re-notifications.              Exhibit 8 provides estimates on the number of LQGs and SQGs who intend to trade with OECD countries, as well as facilities who imported materials from OECD countries. These data were collected and provided by OECA.              SUMMARY OF BURDEN HOURS and COSTS              6(e) Bottom Line Burden Hours and Costs        Based on the above assumptions, affected universes and associated labor and operating costs, EPA estimates that 266,384 burden hours and $15,040,973 ($14,992,809 labor, $48,164 capital & O&M) will be required annually to support recordkeeping and reporting requirements for large and small quantity generators. This equates to 799,151 hours and $45,122,920 ($44,978,428 labor, $144,492 capital & O&M) for the three year period of this ICR. See Exhibit 9 for calculations.              EPA also estimates that the burden to the Federal Government will be 4,000 hours and an annual cost of $130,646.              6(f) Changes in Estimated Burden              EPA estimates a decrease of 20,482 annual hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burden of 286,866 hours.  This change primarily results from a decrease of 12,586 facilities, or 12.4 percent in the estimated universe of small and large quantity generators. 	 	6(f) Reasons for Change in Burden

	The primary reason for the change in burden is the reduction of the number of hazardous waste generators, particularly small quantity generators between 2007 and 2010.

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

      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-RCRA-2010-0833, which is available for online viewing at www.regulations.gov, or in person viewing at the RCRA Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for RCRA Docket is<PHONE_NUMBER>. An electronic version of the public docket is available at www.regulations.gov.  This site can be used 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.  When in the system, select "search," then key in the Docket ID Number identified above.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-RCRA-2010-0833 and OMB Control Number 2050-0035 in any correspondence.

Drip Pad Requirements (262.34(a)(1)(iii)) Contingency Plan (265.440(c)(1))    Write contingency plan 1 0.00 0.00 2.00 0.00 $0.00 $0.00 $0.00 2 $106.50 $107    Document clean-up of incidental drippage 1 0.00 0.00 0.25 0.25 $0.00 $0.00 $0.00 1 $21.32 $21    Retain documentation for 3 years 1 0.00 0.00 0.00 0.10 $0.00 $0.00 $0.00 0 $3.20 $3 Assess adequacy of drip pads (265.441(a)(b)(c))      Prepare and maintain assessment of pad integrity 0 0.00 0.00 2.00 1.00 $0.00 $0.00 $0.00 0 $138.53 $0    Prepare plan for upgrading pad 0 0.00 0.10 5.00 1.00 $0.00 $0.00 $0.00 0 $305.43 $0    Prepare drawings of pad and obtain independent certification 0 0.00 0.20 6.50 0.30 $0.00 $0.55 $0.07 0 $370.65 $0 Design and Operating Requirements (265.443)      Prepare an assessment of drip pad and obtain certification 9 0.00 0.25 4.00 0.25 $0.00 $0.00 $0.00 41 $238.88 $2,150    Place a record of any condition contributing to or actual                            release of hazardous waste from drip pad in operating log 1 0.00 0.00 0.25 0.00 $0.00 $0.00 $0.00 0 $13.31 $13    Notify Regional Administrator of release & provide written notice 1 0.17 0.10 0.40 0.00 $4.48 $0.55 $2.00 1 $56.03 $56    Notify Regional Adminstrator of completion of repairs 1 0.00 0.10 0.40 0.00 $4.48 $0.22 $0.00 1 $33.15 $33    Provide Regional Administrator independent certification                            that repairs satisfy applicable standards 1 0.00 0.10 1.00 0.10 $4.48 $0.55 $0.07 1 $68.70 $69    Prepare documentation of operating/waste handling practices 9 0.00 0.00 2.00 0.00 $0.00 $0.55 $0.07 18 $107.12 $964 Certification of liner (265.444(a))      Obtain independent certification of liner 9 0.00 0.00 2.00 0.10 $0.00 $0.00 $0.00 19 $109.70 $987    Place certification in operating log 9 0.00 0.00 0.00 0.10 $0.00 $0.00 $0.00 1 $3.20 $29 Documentation of waste removal (262.34(a)(1)(iii))        Prepare description of 90-day waste removal practices 9 0.00 0.00 0.25 0.00 $0.00 $0.00 $0.00 2 $13.31 $120    Document each waste removal 9 0.00 0.00 0.25 0.00 $0.00 $0.00 $0.00 2 $13.31 $120 Subtotal varies 0.00 varies varies varies $13.44 $6.27 $2.66 88 varies $4,672 Containment Building Requirements (262.34(a)(1)(iv)) Design and Performance Documentation (265.1101(c)(d))    Obtain independent certification of building design 14 0.00 0.00 2.00 0.10 $0.00 $0.00 $0.00 29 $109.70 $1,536    Place certification in operating record 14 0.00 0.00 0.00 0.10 $0.00 $0.00 $0.00 1 $3.20 $45    Maintain records of any release from containment building 4 0.00 0.00 0.25 0.10 $0.00 $0.00 $0.00 1 $16.52 $66    Notify Regional administrator of any condition contributing to                            or actual release of hazardous waste and follow-up notice 4 0.00 0.00 2.00 0.00 $0.00 $0.00 $0.00 8 $106.50 $426    Notify Regional Administrator of clean-up or repairs 4 0.17 0.10 0.40 0.10 $0.00 $0.00 $0.00 3 $52.21 $209    Record monitoring and leak detection data and place in                            operating record at least every 7 days 14 0.00 0.00 0.00 10.00 $0.00 $0.00 $0.00 140 $320.30 $4,484 Documentation of Areas Lacking Secondary Containment (265.1101(d)        Place in operating log description of procedures to maintain                            integrity of areas lacking secondary containment 14 0.00 0.00 2.00 0.10 $0.00 $0.00 $0.00 29 $109.70 $1,536 Documentation of Procedures and Compliance (262.34(a)(1)(iv))        Prepare procedures ensuring waste is stored no more                            than 90 days 14 0.00 0.00 1.00 0.10 $0.00 $0.00 $0.00 15 $56.45 $790    Prepare description of waste generation and waste                            management practices 14 0.00 0.00 1.50 0.10 $0.00 $0.00 $0.00 22 $83.08 $1,163    Document that 90-day storage procedures are satisfied 14 0.00 0.00 0.25 0.00 $0.00 $0.00 $0.00 4 $13.31 $186    Document that unit is emptied at least once every 90 days 14 0.00 0.00 1.00 0.40 $0.00 $0.00 $0.00 20 $66.06 $925 Subtotal varies 0.00 varies varies varies $0.00 $0.00 $0.00 274 937 $11,366 Requests for Extensions of Accumulation Period (262.34(b))        Prepare and submit request to Regional Administrator 140 0.10 0.10 0.00 0.40 $4.48 $0.00 $0.00 84 $36.53 $5,114 Subtotal 140 0.10 0.10 0.00 0.40 $627.20 $0.00 $0.00 84 $659.25 $5,114 Subtotal for LQG Pre-Transport Requirements varies 0.00 varies varies varies $3,216.64 $1,056.62 $2,666.89 39,001 varies $1,946,704


[Federal Register: June 14, 2010 (Volume 75, Number 113)]
[Notices]
[Page 33615-33616]
[DOCID:fr14jn10-50]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9162-4; Docket ID No. EPA-HQ-ORD-2010-0395]

Draft EPA's Reanalysis of Key Issues Related to Dioxin Toxicity
and Response to NAS Comments (EPA/600/R-10/038A)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Listening Session.

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SUMMARY: EPA is announcing a listening session to be held on July 9,
2010, during the public comment period for the external review draft
document entitled ``EPA's Reanalysis of Key Issues Related to Dioxin
Toxicity and Response to NAS Comments'' (EPA/600/R-10/038A). The EPA's
draft document and peer review charge are available via the Internet on
the National Center for Environmental Assessment's (NCEA) home page
under the Recent Additions and Publications menus at http://
www.epa.gov/ncea. This draft document responds to the key
recommendations and comments included in the National Academy of
Sciences (NAS) 2006 report. In addition, it includes new analyses on
potential human effects that may result from exposure to 2,3,7,8-
tetrachlorodibenzo-p-dioxin (TCDD).
    The release of the draft document for public comment was announced
in a May 21, 2010, Federal Register Notice (75 FR 28610). EPA also
announced that it intends to forward all public comments submitted
before July 7, 2010, in response to the May 21, 2010, Notice, to the
EPA Science Advisory Board (SAB) peer review panel for its
consideration and provided instructions for submitting comments.
    The draft document is also being provided to the SAB, a body
established under the Federal Advisory Committee Act, for independent
external peer review. The SAB is convening an expert panel composed of
scientists knowledgeable about technical issues related to dioxins and
risk assessment. The SAB is holding a public teleconference on June 24,
2010, and a public panel meeting on July 13-15, 2010. The SAB peer
review meetings were announced by the SAB staff office in a separate
May 24, 2010, Federal Register Notice (75 FR 28805). Members of the
public who wish to ensure that their technical comments are provided to
the SAB expert panel before each meeting should also e-mail their
comments separately to Thomas Armitage, the SAB Designated Federal
Officer at<EMAIL_ADDRESS>following the procedures in the May
24, 2010, Federal Register Notice announcing the SAB public meetings.
The public comment period and SAB external peer review are independent
processes that provide separate opportunities for all interested
parties to comment on the draft report.
    The purpose of the listening session is to allow all interested
parties to present scientific and technical comments on draft IRIS
health assessments to EPA and other interested parties during the
public comment period and before the external peer review meeting. EPA
welcomes the scientific and technical comments that will be provided to
the Agency by the listening session participants. All comments
submitted according to the detailed instructions provided in the May
21, 2010, Federal Register Notice under SUPPLEMENTARY INFORMATION will
be considered by the Agency as it revises the draft assessment in
response to the independent external peer review and public comments.
All presentations will become part of the official public record.

DATES: The listening session on the draft IRIS health assessment for
dioxin will be held on July 9, 2010, beginning at 9 a.m. and ending at
4 p.m., Eastern Daylight Time. If you would like to make a presentation
at the listening session, you should register by July 2, 2010, indicate
that you wish to make oral comments at the session, and indicate the
length of your presentation. When you register, please indicate if you
will need audio-visual equipment (e.g., laptop computer and slide
projector). In general, each presentation should be no more than 30
minutes. If, however, there are more requests for presentations than
the allotted time allows, then the time limit for each presentation
will be adjusted. A copy of the agenda for the listening session will
be available at the meeting. If no speakers have registered by July 2,
2010, the listening session will be cancelled and EPA will notify those
registered of the cancellation.
    The public comment period for review of this draft assessment was
announced previously in the Federal Register (75 FR 28610) on May 21,
1010. As stated in that Federal Register Notice, the public comment
period began on May 21, 2010, and ends August 19, 2010. Any technical
comments submitted during the public comment period should be in
writing and must be received by EPA by August 19, 2010, according to
the procedures outlined in the May 21, 2010, Federal Register Notice.
Only those public comments submitted by July 7, 2010, or e-mailed
separately to Thomas Armitage, the SAB Designated Federal Officer at
<EMAIL_ADDRESS>following the procedures in the May 24, 2010,
Federal Register Notice announcing the SAB public meetings, will be
provided to the independent peer-review panel prior to the peer-review
meeting. However, all comments received during the public comment
period will be provided to the SAB peer review committee and will also
inform the Agency's revision of the draft assessment.

ADDRESSES: The listening session on the draft dioxin assessment will be
held at the EPA offices at Two Potomac Yard South Building, 4th Floor,
S-4370-80, 2733 South Crystal Drive, Arlington, Virginia 22202. To
attend the listening session, register by July 2, 2010. To present at
the listening session, indicate in your registration that you want to
make oral comments at the session and provide the length of your
presentation. To register, send an e-mail to:
<EMAIL_ADDRESS>(subject line: Dioxin Listening Session);
call Christine Ross at<PHONE_NUMBER>; or fax a registration request to
703-347-8689 (please reference the ``Dioxin Listening Session'' and
include your name, title, affiliation, full address and contact
information). Please note that to gain entrance to this EPA building to
attend the meeting, attendees must have photo identification with them
and must register at the guard's desk in the lobby. The guard will
retain your photo identification and will provide you with a visitor's
badge. At the guard's desk, attendees should give the name Christine
Ross and the telephone number<PHONE_NUMBER> to the guard on duty. The
guard will contact Ms. Ross who will meet you in the reception area to
escort you to the meeting room. When you leave the building, please
return your visitor's badge to the guard and you will receive your
photo identification.
    A teleconference line will also be available for registered
attendees/speakers. The teleconference number is<PHONE_NUMBER>, and the
access code is<PHONE_NUMBER>, followed by the pound sign ().
The teleconference line will be activated at 8:45 a.m., and you will be
asked to identify yourself and your affiliation at the beginning of the
call.

    Information on Services for Individuals with Disabilities: EPA
welcomes public attendance at the ``Dioxin Listening Session'' and will
make every effort to accommodate persons with disabilities. For
information on access or services for individuals with disabilities,
please contact Christine Ross at<PHONE_NUMBER> or
<EMAIL_ADDRESS>To request accommodation of a disability,
please contact Ms. Ross, preferably at least 10 days prior to the
meeting, to give EPA as much time as possible to process your request.

FOR FURTHER INFORMATION CONTACT: For information on the public
listening sessions, please contact Christine Ross, IRIS Staff, National
Center for Environmental Assessment, (8601P), U.S. EPA, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone: 703-347-
8592; facsimile:<PHONE_NUMBER>; or e-mail<EMAIL_ADDRESS>
For questions about the draft dioxin assessment, contact Glenn Rice,
National Center for Environmental Assessment, A110, U.S. EPA, 26 West
Martin Luther King Drive, Cincinnati, OH 45268; telephone: 513-569-
7813; facsimile:<PHONE_NUMBER> or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA's IRIS is a human health assessment
program that evaluates quantitative and qualitative risk information on
effects that may result from exposure to chemical substances found in
the environment. Through the IRIS Program, EPA provides the highest
quality science-based human health assessments to support the Agency's
regulatory activities. The IRIS database contains information for more
than 540 chemical substances that can be used to support the first two
steps (hazard identification and dose-response evaluation) of the risk
assessment process. When supported by available data, IRIS provides
oral reference doses (RfDs) and inhalation reference concentrations
(RfCs) for chronic noncancer health effects and cancer assessments.
Combined with specific exposure information, government and private
entities use IRIS to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.

    Dated: June 8, 2010.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2010-14239 Filed 6-11-10; 8:45 am]
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[Federal Register: April 7, 2009 (Volume 74, Number 65)]
[Notices]
[Page 15741]
[DOCID:fr07ap09-60]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 23, 2009, from
8:30 a.m. to 5:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: James Swink, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850,<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), code<PHONE_NUMBER>. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
    Agenda: The committee will discuss, make recommendations, and vote
on a premarket approval application, sponsored by Atritech, Inc., for
the WATCHMAN[reg] Left Atrial Appendage (LAA) Closure Technology. The
WATCHMAN[reg] device, a percutaneously placed permanent implant, is
intended as an alternative to warfarin therapy for patients with non-
valvular atrial fibrillation. The WATCHMAN[reg] LAA Closure Technology
is designed to prevent embolization of thrombi that may form in the
left atrial appendage thereby preventing the occurrence of ischemic
stroke and systemic thromboembolism.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 16, 2009. Oral presentations from the public will be scheduled
approximately 30 minutes at the beginning of committee deliberations
and approximately 30 minutes near the end of the deliberations. Those
desiring to make formal oral presentations should notify the contact
person and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation on or before April 8, 2009. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by April 9, 2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, at<PHONE_NUMBER>, at least 7 days in
advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-7726 Filed 4-6-09; 8:45 am]

BILLING CODE 4160-01-S