STANDARD FORM 83 SUPPORTING STATEMENT FOR ICR NO. 2164.01 REPORTING AND RECORDKEEPING REQUIREMENTS FOR EMISSION GUIDELINES FOR EXISTING OTHER SOLID WASTE INCINERATION ( OSWI) UNITS ( 40 CFR PART 60, SUBPART FFFF)

U. S. Environmental Protection Agency Office of Air Quality Planning and Standards Research Triangle Park, NC 27711 September 2004 1 PART A OF THE SUPPORTING STATEMENT FOR STANDARD FORM 83 Other Solid Waste Incineration Units 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection.

" Reporting and Recordkeeping requirements for Emission Guidelines for Existing Other Solid Waste Incineration ( OSWI) Units ( 40 CFR Part 60, Subpart FFFF)."

1( b) Short Characterization/ Abstract.

This supporting statement addresses information collection activities imposed by the Emission Guidelines and Compliance Times for Other Solid Waste Incineration ( OSWI)

Units   40 CFR Part 60 Subpart FFFF. The emission guidelines address existing OSWI units that commenced construction before proposal of the emission guidelines.

The emission guidelines do not apply directly to existing OSWI unit owners and operators. The emission guidelines can be thought of as " model regulations" that States use in developing State plans to implement the emission guidelines.

If a State does not develop, adopt, and submit an approvable State plan, the Environmental Protection Agency ( EPA) must develop a Federal plan to implement the emission guidelines.

Whether an OSWI unit is ultimately regulated under a State plan or Federal plan, the full respondent burden for the first 3 years after promulgation of the emission guidelines is included in this ICR. The OSWI units to be regulated include two subcategories: very small municipal waste combustion ( VSMWC) units and institutional waste incineration ( IWI) units.

The use of the term " Designated Administrator"

throughout this document refers to the person or office designated by each State plan to administer the implementation of the plan, or to the U. S. EPA Administrator in the event that a State's plan is not approvable and a 2 Federal plan must be developed. The term " Administrator"

alone refers to the U. S. EPA Administrator.

This ICR presents the burden to respondents and the Designated Administrator ( State or Federal Government).

Respondents are owners or operators of existing OSWI units.

This ICR includes the burden for activities that will be conducted in the first three years following promulgation of the emission guidelines. Attachments A and B contain tables of the respondent and agency burden estimates,

respectively, for years one through three. These activities include reading the rule. Because the compliance date is 5 years after the emission guidelines are promulgated, other activities, such as testing, monitoring, recordkeeping, and reporting do not begin until 5 years after promulgation.

Therefore, they are not included in the burden estimate for the first 3 years. Although not necessary for this ICR,

respondent and agency burden estimates for years 4, 5, and 6 are included in Attachments C and D to provide perspective on the annual burden when the rule is fully implemented.

The requirements described below are the minimum requirements established by the emission guidelines.

Although States may choose to impose more stringent requirements, it is assumed for this burden estimate that the State plans mirror the emission guidelines.

2. AUTHORITY/ NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection The EPA is charged under section 111( c) of the Clean Air Act ( CAA), as amended, to establish procedures by which:

. . . each State shall submit to the Administrator a plan which ( A) establishes standards of performance for any existing source for any air pollutant. . . to which a standard of performance would apply if such existing source were a new source, and ( B) provides for the 3 implementation and enforcement of such standards of performance.

The EPA is required, under section 129 of the CAA, to establish guidelines for existing stationary sources that reflect the maximum achievable control technology ( MACT) for achieving continuous emission reductions:

Section 129( a)( 1) states:

The Administrator shall establish performance standards and other requirements pursuant to section 111 and this section for each category of solid waste incineration units. Such standards shall include emissions limitations and other requirements applicable to new units and guidelines ( under section 111( d) and this section) and other requirements applicable to existing units.

Section 129( a)( 2) states:

Standards applicable to solid waste incineration units promulgated under section 111 and this section shall reflect the maximum degree of reduction in emissions of air pollutants listed under section ( a)( 4) that the Administrator, taking into consideration the cost of achieving such emission reduction, and any non air quality health and environmental impacts and energy requirements, determines is achievable for new or existing units in each category.

Section 129( b)( 1) states:

Performance standards under this section and section 111 for solid waste incineration units shall include guidelines promulgated pursuant to section 111( d) and this section applicable to existing units. Such guidelines shall include, as provided in this section, each of the elements required by subsection ( a) ( emissions limitations, notwithstanding any restriction in section 111( d) regarding issuance of such limitations), subsection ( c) ( monitoring), subsection ( d) ( operator training), subsection ( e), ( permits), and subsection ( h)( 4) ( residual risk).

Subpart B of 40 CFR Part 60 requires State plans to include monitoring, recordkeeping, and reporting provisions 4 consistent with the emission guidelines. In addition,

section 114( a)( 1) states that:

. . . the Administrator may require any person who owns or operates any emission source or who is 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, ( D) sample such emissions ( in accordance with such methods, at such locations, at such intervals, and in such manner as the Administrator shall prescribe), and ( E) provide such other information, as he may reasonably require.

Certain reports are necessary to enable a Designated Administrator to identify existing sources subject to the State plan that implements the emission guidelines and to determine if the guidelines are being achieved.

2( b) Practical Utility/ Users of the Data.

The information will be used by the Designated Administrators' enforcement personnel to ensure that the requirements of the State ( or Federal) plan are being implemented and are complied with on a continuous basis.

Specifically, the information will be used by the Designated Administrator to: ( 1) Identify existing sources subject to the emission guidelines; ( 2) ensure that subpart FFFF is being properly applied; ( 3) ensure that the emission limits are being complied with; ( 4) ensure, on a continuous basis,

that the operating limits established during the initial performance test are not exceeded.

In addition, records and reports are necessary to enable the Designated Administrator to identify OSWI units that may not be in compliance with the emission guidelines.

Based on reported information, the Designated Administrator can decide which OSWI units should be inspected and what records or processes should be inspected at the OSWI unit.

The records that OSWI units maintain would indicate to the 5 Designated Administrator whether the personnel are operating and maintaining control equipment properly and whether they have met the qualification requirements.

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Nonduplication.

This ICR contains reporting and recordkeeping requirements for OSWI units, whether regulated under a State plan or Federal plan. No information is required to be submitted in the first 3 years following promulgation of the emission guidelines.

Other activities, such as emissions testing, operator training, and monitoring of operating parameters, do not occur until 5 years after promulgation. This is because the final compliance date for existing facilities occurs 5 years after promulgation of the emission guidelines or 3 years after EPA approval of a State plan.

In most cases, the enforcement of emission guidelines has been delegated to State air pollution control agencies.

In such cases, the reports required by the emission guidelines will be submitted to the appropriate State agency, and not directly to the EPA. Thus, there is a minimal possibility for the submittal of duplicate information to State agencies and EPA. In those few cases where State agencies have not developed a State plan or requested delegation of the Federal plan, Federal enforcement still requires information from the OSWI facility. The facility owner or operator may submit a copy of State or local reports to the Administrator in lieu of the report required by the emission guidelines if it contains the necessary information, as specified in the General Provisions of 40 CFR Part 60.

3( b) Public notice prior to ICR submission to OMB. 6 A public notice of this collection will be provided in the notice of proposed rulemaking for the emissions guidelines.

3( c) Consultations.

While collecting technical information pertaining to the OSWI category, EPA contacted incinerator manufacturers and associations as well as State and Federal agencies. In addition to these contacts, EPA chartered an Industrial Combustion Coordinated Rulemaking advisory committee in 1996, under the Federal Advisory Committee Act. The committee's objective was to develop recommendations for regulations for several combustion source categories under sections 112 and 129 of the CAA. The EPA considered information received from all of these sources in the development of the proposed emission guidelines.

The public will also have the opportunity to review and comment on the proposed emission guidelines and the ICR during the specified comment period.

3( d) Effects of Less Frequent Data Collection.

The emission guidelines require initial and annual performance tests for nine pollutants and opacity,

continuous emission monitoring for carbon monoxide ( CO),

continuous operating parameter monitoring, annual operator training, and annual reporting ( semiannual deviation reports are required if any of the emission limits or operating limits are exceeded). The frequency of these activities was chosen by EPA as the period that will provide an adequate margin of assurance that affected facilities will not operate for extended periods in violation of the emission guidelines.

No reports or data collection efforts are submitted in the first 3 years after promulgation of the emission guidelines. The only burden for owners and operators in the first 3 years is to read and understand the emission 7 guidelines. The other activities take place after the compliance date, which will be in the fifth year after promulgation.

3( e) General Guidelines.

With the exception of requiring records to be maintained for more than 3 years, none of the guidelines in 5 CFR 1320.5 are being exceeded. This rule requires all records to be maintained at the source for a period of 5 years. In 40 CFR Part 63, Subpart A, " General Provisions for National Emission Standards for Hazardous Air Pollutants for Source Categories," owners or operators of facilities are required to keep and maintain records for a period of 5 years. These records must be kept on file for use, if needed, by the regulating authority to ensure that the plant personnel are operating and maintaining control equipment properly. Under section 129 of the CAA, OSWI facilities are subject to regulation under similar maximum achievable control technology ( MACT) based regulations, therefore, this 5 year record retention requirement was adopted for OSWI facilities. Furthermore, section 129 requires all OSWI units to obtain title V operating permits under part 70 or 71 permit programs. The title V permit programs also require records to be retained for 5 years. To minimize the burden, the emission guidelines allow files to be kept in paper or electronic format. Files must be kept on site for 2 years but may be kept off site for the remaining 3 years.

3( f) Confidentiality and Sensitive Questions.

( i) Confidentiality. All information submitted to EPA for which a claim of confidentiality is made will be safeguarded according to EPA 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 39999, September 28, 1978; 43 FR 42251,

September 28, 1978; 44 FR 17674, March 23, 1979). 8 ( ii) Sensitive Questions. This section is not applicable because this ICR does not involve matters of a sensitive nature.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ NAICS Codes.

Respondents are owners or operators of OSWI units for which construction commences on or before the date of proposal publication in the Federal Register. OSWI units include VSMWC units that combust less than 35 tons per day of waste collected from multiple residences, businesses,

etc., that are operated by municipalities ( NAICS 562213,

92411). OSWI units also include IWI units, as defined in the regulation, that are located at an institutional facility and combust waste generated at that facility. IWI units can be located at institutions such as schools,

universities, prisons, military bases, government facilities, churches and other institutions with NAICS 623,

922, 928, 6111, 6112, 6113, 7121, 8131, or 8134.

4( b) Information Requested.

( i) Data items. The recordkeeping and reporting requirements of the proposed emission guidelines are described in section 4( b)( iii) and include the following:

° notification of final compliance ( no information is required in the first 3 years);

° waste management plan;

° records of operator training and qualification;

° performance test reports;

° records of CO and operating parameter monitoring;

° annual compliance reports; and ° semiannual deviation reports.

( ii) Respondent activities. The respondent activities required by the emission guidelines are provided under the 9 first column of Tables A1 through A3 in Attachment A and are summarized in section ( 4)( b)( iii). All respondent burden items are included in Tables A1 through A3, however, as previously explained, the only respondent activity in the first 3 years will be reading the rules.

( iii) Summary of emission guidelines requirements.

There are no information collection activities in the first 3 years after promulgation of the proposed emission guidelines.

Any information collection activities included in the emission guidelines will not occur until at least 5 years following promulgation. Therefore, the burden for these items is not included in the ICR, however, burden estimate tables have been included as Attachment C. These items include: preparation of a waste management plan,

performance tests, CO emissions monitoring, operating parameter monitoring, operator training, one time and periodic reports, and the maintenance of records.

Testing and Monitoring: The emission guidelines require an initial performance test for particulate matter ( PM), dioxins/ furans, opacity, hydrochloric acid ( HCl),

cadmium ( Cd), lead ( Pb), mercury ( Hg), CO, nitrogen oxides ( NOx) and sulfur dioxide ( SO2). During the initial performance test, the owner or operator must establish limits for each operating parameter. Thereafter, the owner or operator must conduct annual performance tests for the nine pollutants and opacity, and must continuously monitor CO and the operating parameters. The emission guidelines allow the owner or operator to skip two annual performance tests for a pollutant if all performance tests over the previous 3 years show compliance with the emission limit.

Operating Training: To ensure the proper operation of the incinerator, the emission guidelines require that each facility establish and maintain at least one qualified OSWI 10 unit operator or supervisor. The operator qualification process includes training, an exam, and review of sitespecific materials. The operator qualification requirements allow the flexibility to use State approved training and qualification programs. To maintain qualification the operators or supervisors must attend an annual refresher course and review site specific materials annually.

Reporting: On or before the compliance date specified by the State or Federal plan implementing the emission guidelines, the owner or operator must submit a notification that includes a statement of compliance with the emission guidelines. Another report, the waste management plan,

identifies both the feasibility and the approach to separate certain components of solid waste from the waste stream to reduce the amount of toxic emissions from incinerated waste.

The final compliance notification and waste management plan are documents that need to be prepared and submitted only once.

Following the initial performance test, the owner or operator must submit a report that documents the results of the performance test for the nine pollutants and opacity and the values for the facility's operating limits.

An annual compliance report is required that documents the values for the operating limits, performance test results and any deviations from the emission limits,

operating limits or other requirements.

If there is a deviation from the operating limits or emission limits, the owner or operator must submit a deviation report that provides details on the deviation.

These reports are submitted semiannually if a deviation occurs during the 6 month period.

Recordkeeping: As specified in the emission guidelines, owners or operators of OSWI units are required to keep records of certain parameters and information for a 11 period of 5 years. Owners or operators are required to maintain records of the initial performance test, annual performance tests, and any subsequent performance tests.

Owners or operators must also maintain records of the monitoring data for CO and the operating parameters, and records of monitoring device calibration.

Records must be maintained for any incinerator malfunctions, any deviations from the operating limits, and days for which CO or operating parameter monitoring data were not obtained.

Owners or operators must maintain the names of persons who have completed the review of site specific information and who have met the operator qualification requirements.

Records of all documentation for the waste management plan must also be maintained.

5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES,

COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities.

A list of Agency activities is provided in section 6( c)

and in Tables B1 through B3 in Attachment B.

5( b) Collection Methodology and Management.

This collection of information does not require the use of automated collection techniques because of the relatively small number of respondents, if any, that will be affected.

See section 5( d) Collection Schedule.

5( c) Small Entity Flexibility.

The EPA does not expect the emission guidelines to have a significant small business impact. Therefore, the rule does not contain any provisions reserved exclusively for the benefit of small entities. However, the rule does contain provisions that reduce the impact of the rule on all regulated entities, which include small entities. Such provisions include: operating parameter monitoring is 12 required instead of continuous emissions monitoring systems( CEMS) for pollutants other than CO; the owner or operator is allowed to skip two annual performance tests for a pollutant if all performance tests over the previous 3 years show compliance; and deviation reports are only required if there is a deviation, otherwise reporting is annual.

5( d) Collection Schedule.

In the first 3 years following promulgation of the emission guidelines, owners or operators would only read the rule.

In year 5 the information collected includes the following one time only activities: initial performance tests ( PM, dioxins/ furans, opacity, HCl, Cd, Pb, Hg, CO,

NOx, SO2), initial operator training and qualification,

waste management plan, and report following initial performance test ( includes operating parameter values). The data will be entered into the Aerometric Information Retrieval System ( AIRS), operated and maintained by EPA's Office of Air Quality Planning and Standards.

After year 5, annual performance tests are required for the nine pollutants listed above and opacity. Continuous emission monitoring for CO and continuous parameter monitoring is required. An annual operator training refresher course and site specific information review is required.

An annual report is required that includes compliance data on the operating limits, performance test results, and identification of deviations from emission limits, operating limits, or other requirements.

Additionally, if the operating limits or emission limits are exceeded, the owner or operator must submit a deviation report that provides details on the deviation. If all qualified operators are unavailable for more than 2 13 weeks, a status report must be submitted within 10 days and a corrective action summary must be submitted every 4 weeks until compliance is achieved.

Information obtained from annual compliance reports will be published and distributed through the compliance data system ( CDS). Data obtained during periodic visits by EPA personnel from records maintained by the respondents will be tabulated and published for internal EPA use in compliance and enforcement programs.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden.

The burden estimates are based on a population of 372 existing OSWI units in EPA's inventory. Tables A1 through A3 in Attachment A present an itemized breakdown of the reporting and recordkeeping requirements in the first 3 years for the respondents subject to the emission guidelines. The annual cost and labor burden estimates for reporting and recordkeeping show that the only requirement in the first 3 years is reading and understanding the emission guidelines.

6( b) Estimating Respondent Costs.

The information collection activities for sources subject to these requirements are presented in Tables A1 through A3 in Attachment A. The total cost for each respondent activity includes labor costs, capital/ startup costs, and operating and maintenance ( O& M) costs.

( i) Estimating Labor Costs. Labor rates, on a perhour basis, are taken from the Bureau of Labor Statistics ( BLS) Web site as posted in March 2004. Attachment E contains the labor rate query results from the BLS Web site.

The occupational category that is the most similar to personnel at facilities operating OSWI units is assumed to be " State and local Government." The labor rates from the 14 fourth quarter of 2003 have been multiplied by a factor of 1.6 so that overhead and benefits are included in the perhour labor rates used to estimate respondent costs. The rates used are $ 46.02 for technical personnel, $ 67.04 for management and $ 34.66 for clerical personnel.

( ii) Estimating Capital/ Start up Costs.

There are no capital costs associated with the emission guidelines in the first 3 years.

( iii) Total Operation and Maintenance ( O& M), and Purchase of Service Costs.

There are no operational or maintenance costs associated with the emission guidelines in the first 3 years.

6( c) Estimating Agency Burden and Cost.

Because the information collection requirements were developed as an incidental part of the emission guidelines development, no costs can be attributed to the development of the additional information collection requirements.

Publication and distribution of the information are part of the AIRS Facility subsystem, with the result that no Federal costs can be directly attributed to the ICR. Examination of records to be maintained by the respondents would occur incidentally as part of the periodic inspection of sources that is part of the Designated Administrator's overall compliance and enforcement program and, therefore, could not be attributable to the ICR.

The only costs that the Implementing Agency would incur in the first 3 years are reading and understanding the rule,

and preparing an annual report that summarizes progress in implementing State plans and the compliance status of the affected facilities in each State. These items are presented in Tables B1 through B3 in Attachment B. Under 40 CFR Part 60, Subpart B, the first annual State progress reports are required at the end of the first full calendar 15 year after approval of the State plan or promulgation of the Federal plan. Section 129 of the CAA allows 1 year for States to submit a State plan. The EPA would approve the plan or promulgate a Federal plan, if needed, in the second year. Year three will be the first year after approval of State plans or promulgation of the Federal plan and,

therefore, the first year States or EPA need to submit State progress reports.

Labor rates for the Designated Administrator's employees are also based on the estimated hourly rates for " State and local Government," as described above for the respondent labor costs, and are: $ 46.02 for technical personnel; $ 67.04 for management personnel; and $ 34.66 for clerical personnel.

6( d) Estimating the Respondent Universe and Total Burden Costs.

The total number of respondents is also referred to as the respondent universe. The respondent universe for this ICR is based on EPA's OSWI inventory database, which shows 372 OSWI units currently in operation. Each respondent owns/ operates one OSWI unit. Industry burden is calculated based on the assumption that all existing OSWI units will remain in use during years one through three.

6( e) Bottom Line Burden Hours and Cost Tables.

( i) The Respondent Tally. A breakdown for each of the collection, reporting, and recordkeeping activities required by the emission guidelines is presented in Tables A1 through A3 in Attachment A. The estimate of total annual hours requested from the respondents was based on the assumptions outlined in section 6( d) of this ICR. The EPA estimated the respondent burden for the first 3 years after adoption of the emission guidelines by totaling the hours per year for technical, managerial, and clerical staff at the facility.

Due to the absence of capital or start up costs in the first 16 3 years, there are no annualized capital costs. There are also no operating and maintenance costs in the first 3 years. The average annual respondent burden for the 3 year period is 5,704 hours and $ 262,055 of labor costs.

( ii) The Designated Administrator. The bottom line Designated Administrator burden hours and costs, presented in Tables B1 through B3 in Attachment B, were calculated by totaling the hours per year for technical, managerial, and clerical staff, and by totaling the cost column. The average annual Agency burden over the first 3 years is 383 hours and $ 17,611 of labor costs. There are no capital,

start up or operating and maintenance costs in the first 3 years.

( iii) Variations in the annual bottom line. The total respondent costs for years 1, 2, and 3 are $ 786,164, $ 0 and $ 0, respectively. The corresponding total number of respondent hours during this period are 17,112 hours, 0 hours, and 0 hours ( see Table A4 in Attachment A). The only activity during this period is reading and understanding the rule.

Most of the burden of the rule, such as initial and annual performance tests, operator training and qualification, monitoring of operating parameter values, and reporting and recordkeeping for these activities, will not occur until year 5. Therefore, the respondent burden for years 1 through 3 is minimal.

During the first 3 years, the Designated Administrators will be reviewing the regulation, and preparing annual summary reports. In years 1, 2, and 3, the Designated Administrators will expend 920, 0, and 230 total hours in labor, respectively. The corresponding costs for each year are $ 42,267, $ 0, and $ 10,567 ( see Table B4 in Attachment B). 17 6( f) Reasons for change in burden.

This is the first submittal of this burden estimate;

therefore, this section is not applicable.

6( g) Burden Statement.

The annual public reporting and recordkeeping burden for this collection of information is estimated to average 46 hours per response. Burden means 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.

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. OAR 2003 0156, which is available for public viewing at the Air and Radiation Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West Building, Room B102,

1301 Constitution Ave., NW, Washington, DC 20460. The EPA 18 Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays.

The telephone number for the Reading Room is ( 202) 566 1744,

and the telephone number for the Air Docket is ( 202) 566

1742. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID No. ( OAR 2003 0156) in any correspondence. PART B OF THE SUPPORTING STATEMENT This section is not applicable because statistical methods are not used in data collection associated with this regulation. ATTACHMENT A TABLES A1, A2, A3, and A4 ( For Tables A1 through A3, see Excel Spreadsheet EG OSWI Cost yrs 1 6)

Table A1: Annual Respondent Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 1 Table A2: Annual Respondent Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 2 Table A3: Annual Respondent Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 3 Table A4: Summary of Respondent Burden for Emission Guidelines  Years 1 through 3 TABLE A4. SUMMARY OF RESPONDENT BURDEN FOR EMISSION GUIDELINES  YEARS 1 THROUGH 3 Non Labor Costs Year Technical Hours Management Hours Clerical Hours Contractor Hours Total Hours Labor Costs Capital O& M Total Cost Year 1 14,880 744 1,488 0 17,112 $ 786,164 0 0 $ 786,164 Year 2 0 0 0 0 0 0 0 0 0 Year 3 0 0 0 0 0 0 0 0 0 Totals 14,880 744 1,488 0 17,112 $ 786,164 0 0 $ 786,164 Average Burden Per Year 4,960 248 496 0 5,704 $ 262,055 0 0 $ 262,055 Note: All figures are rounded to nearest dollar or hour. ATTACHMENT B TABLES B1, B2, B3, and B4 ( For Tables B1 through B3, see Excel Spreadsheet EG OSWI Cost yrs 1 6)

Table B1: Annual Designated Administrator Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 1 Table B2: Annual Designated Administrator Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 2 Table B3: Annual Designated Administrator Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 3 Table B4: Summary of Designated Administrator Burden for Emission Guidelines  Years 1 through 3 TABLE B4. SUMMARY OF DESIGNATED ADMINISTRATOR FOR EMISSION GUIDELINES  YEARS 1 THROUGH 3 Agency Burden Summary: Technical Hours Management Hours Clerical Hours Total Hours Labor Costs Year 1 800 40 80 920 $ 42,267 Year 2 0 0 0 0 0 Year 3 200 10 20 230 $ 10,567 Totals 1,000 50 100 1,150 $ 52,834 Average Burden Per Year 333 17 33 383 $ 17,611 Note: All figures are rounded to the nearest dollar or hour. ATTACHMENT C TABLES C1, C2 and C3 ( For Tables C1 through C3, see Excel Spreadsheet EG OSWI Cost yrs 1 6)

Table C1: Annual Respondent Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 4 Table C2 A: Annual Respondent Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 5 ( All Comply)

Table C2 B: Annual Respondent Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 5 ( All Close)

Table C3 A: Annual Respondent Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 6 ( All Comply)

Table C3 B: Annual Respondent Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 6 ( All Close) ESTIMATED RESPONDENT BURDEN FOR YEARS 4, 5, and 6 The following tables display the estimated respondent burden for the fourth, fifth and sixth years following promulgation of the OSWI emission guidelines ( 40 CFR 60 subpart FFFF). These tables are presented as an example of the burden expected beyond the first three years discussed in the supporting statement and presented in attachment A.

The burden increases in year 5 because the compliance date for the emission guidelines is 5 years after promulgation.

Table C1 presents the burden and costs for year 4 following promulgation. During this year, there are no required activities such as testing, reporting,

recordkeeping, etc. and, as such, no expected costs to respondents. We anticipate that any activities needed to demonstrate compliance with the emission guidelines, such as CEMS installation and emissions testing, will not occur until year 5.

Tables C2 A and C2 B present the year 5 respondent burden and cost for two possible scenarios which may occur with existing OSWI units   one where all units comply with the emission guidelines ( C2 A), and another where all units close and utilize alternative waste disposal options ( C2 B).

The EPA's experience with other CAA section 129 regulations has shown that sources will likely respond to the emission guidelines by choosing to shut down existing waste incineration units and utilizing alternative waste disposal options rather than incur the costs of compliance. The EPA's objective is not to encourage the use of alternatives or to discourage continued use of VSMWC units or IWI units;

EPA's objective is to adopt emission guidelines for existing OSWI units that fulfill the requirements of CAA section 129.

In doing so, however, the primary outcome associated with the adoption of these emission guidelines is projected to be an increase in the use of alternative waste disposal and a decrease in the use of VSMWC and IWI units. As a result, we present burden and cost estimates for both possible scenarios for existing OSWI units.

Table C2 A presents the burden and cost associated with initial compliance demonstration, including CEMS costs and the initial performance test, assuming that all existing OSWI units choose to comply with the emission guidelines.

Table C2 B presents the year 5 respondent burden and cost for all existing OSWI units, assuming that all units close down and utilize alternative waste disposal options.

The tables for year 6 also present the two scenarios presented for year 5. Table C3 A presents the year 6 respondent burden assuming that all existing OSWI units comply with the emission guidelines. Ongoing compliance demonstration activities and associated recordkeeping and reporting activities, such as continuous monitoring, annual emissions testing, annual compliance reporting, and deviation reporting are included. While not shown on this table, it is noteworthy that the emission guidelines provide provisions for sources to skip annual performance testing if they have demonstrated sustained good performance ( i. e., if you have at least three consecutive annual tests that show that you comply with the emission limit for a pollutant,

then you do not have to conduct a performance test for that pollutant for the next 2 years). Therefore, the annual burden may decrease in later years as sources become eligible for the skip testing provisions. Table C3 B, which shows no costs or burden, presents the year 6 respondent burden assuming all existing OSWI units close down and utilize alternative waste disposal options. ATTACHMENT D TABLES D1, D2, and D3 ( For Tables D1 through D3, see Excel Spreadsheet EG OSWI Cost yrs 1 6)

Table D1: Annual Designated Administrator Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 4 Table D2 A: Annual Designated Administrator Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 5 ( All Comply)

Table D2 B: Annual Designated Administrator Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 5 ( All Close)

Table D3 A: Annual Designated Administrator Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 6 ( All Comply)

Table D3 B: Annual Designated Administrator Burden and Cost of Recordkeeping and Reporting Requirements of the Emission Guidelines for OSWI Facilities Subject to Subpart FFFF  Year 6 ( All Close) ESTIMATED DESIGNATED ADMINISTRATOR BURDEN FOR YEARS 4, 5, and 6 The following tables display the estimated Designated Administrator burden for the fourth, fifth and sixth years following promulgation of the OSWI emission guidelines ( 40 CFR 60 subpart FFFF). These tables are presented as an example of the burden expected beyond the first three years discussed in the supporting statement and presented in attachment B. The burden increases in year 5 because the compliance date for the emission guidelines is 5 years after promulgation.

Table D1 presents the burden and costs for year 4 following promulgation. During this year, the only required Designated Administrator activity is the preparation of an annual summary report. We anticipate that activities needed to demonstrate compliance with the emission guidelines, such as observing and reviewing initial performance tests and review of final compliance reports, will not occur until year 5.

Tables D2 A and D2 B present the year 5 Designated Administrator burden and cost for two possible scenarios which may occur with existing OSWI units   one where all units comply with the emission guidelines ( D2 A), and another where all units close and utilize alternative waste disposal options ( D2 B). The EPA's experience with other CAA section 129 regulations has shown that sources will likely respond to the emission guidelines by choosing to shut down existing waste incineration units and utilizing alternative waste disposal options rather than incur the costs of compliance. The EPA's objective is not to encourage the use of alternatives or to discourage continued use of VSMWC units or IWI units; EPA's objective is to adopt emission guidelines for existing OSWI units that fulfill the requirements of CAA section 129. In doing so, however, the primary outcome associated with the adoption of these emission guidelines is projected to be an increase in the use of alternative waste disposal and a decrease in the use of VSMWC and IWI units. As a result, we present burden and cost estimates for both possible scenarios for existing OSWI units.

Table D2 A presents the burden and cost associated with initial compliance demonstration, including observation of the initial performance tests, review of final compliance notifications, waste management plan reviews, and initial compliance test report reviews, assuming that all existing OSWI units choose to comply with the emission guidelines.

Table D2 B presents the year 5 Designated Administrator burden and cost, assuming that all units close down and utilize alternative waste disposal options.

The tables for year 6 also present the two scenarios as with year 5. Table D3 A presents the year 6 Designated Administrator burden assuming that all existing OSWI units comply with the emission guidelines. Ongoing compliance demonstration activities, such as observing annual performance tests, review of semi annual deviation reports,

and review of annual compliance reports are included in the cost and burden. While not shown on this table, it is noteworthy that the emission guidelines provide provisions for sources to skip annual performance testing if they have demonstrated sustained good performance ( i. e., if you have at least three consecutive annual tests that show that you comply with the emission limitation for a pollutant, then you do not have to conduct a performance test for that pollutant for the next 2 years). Therefore, the annual burden associated with observing annual performance tests may decrease in later years as sources become eligible for the skip testing provisions. Table D3 B, which shows no costs or burden, presents the year 6 Designated Administrator burden assuming all existing OSWI units close down and utilize alternative waste disposal options. ATTACHMENT E BUREAU OF LABOR STATISTICS INFORMATION ( For the BLS Web site printouts, see Adobe PDF file BLSdata. pdf)


[Federal Register Volume 84, Number 118 (Wednesday, June 19, 2019)]
[Notices]
[Pages 28601-28602]
[FR Doc No: 2019-12925]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86101; File No. SR-FINRA-2019-014]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Designation of a Longer Period for
Commission Action on a Proposed Rule Change To Allow Additional Time
for Reporting to TRACE of Transactions in U.S. Treasury Securities
Executed To Hedge a Primary Market Transaction

June 13, 2019.
    On April 16, 2019, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend FINRA Rule 6730 to provide additional
time for reporting to TRACE of transactions in U.S. Treasury Securities
executed to hedge a primary market transaction. The proposed rule
change was published for comment in the Federal Register on April 30,
2019.\3\ The Commission received one comment letter in support of the
proposed rule change.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 85713 (April 24,
2019), 84 FR 18329.
    \4\ See Letter from Robert Toomey, Managing Director and
Associate General Counsel, SIFMA, to Robert W. Errett, Deputy
Security, Commission, dated May 21, 2019.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule

change, or within such longer period up to 90 days as the Commission
may designate if it finds such longer period to be appropriate and
publishes its reasons for so finding, or as to which the self-
regulatory organization consents, the Commission shall either approve
the proposed rule change, disapprove the proposed rule change, or
institute proceedings to determine whether the proposed rule change
should be disapproved. The 45th day after publication of the notice for
this proposed rule change is June 14, 2019. The Commission is extending
this 45-day time period.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposal so that it has
sufficient time to consider certain issues raised by the proposed rule
change. Accordingly, the Commission, pursuant to Section 19(b)(2) of
the Act, designates July 29, 2019, as the date by which the Commission
shall either approve or disapprove, or institute proceedings to
determine whether to disapprove, the proposed rule change (File No. SR-
FINRA-2019-014).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-12925 Filed 6-18-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Notices]
[Page 32823]
[FR Doc No: 2016-12128]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2016-16]

Petition for Exemption; Summary of Petition Received; Columbia
Helicopters, Inc.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before June 13, 2016.

ADDRESSES: Send comments identified by docket number FAA-2016-0604
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Brent Hart<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 9, 2016.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2016-0604.
    Petitioner: Columbia Helicopters, Inc.
    Section(s) of 14 CFR Affected: 61.63(d)(1), 61.63(e)(1) and
61.157(g).
    Description of Relief Sought: The petitioner seeks the exemption to
allow Columbia Helicopters, Inc. (CHI) pilot applicants to utilize CHI-
owned Boeing Model 234 helicopters to demonstrate instrument maneuvers
as well as to use the Model 234 to take the practical test for an
``Aircraft Type Rating Limited to VFR'' in the ATP Practical Test
Standards for Helicopters.

[FR Doc. 2016-12128 Filed 5-23-16; 8:45 am]
 BILLING CODE 4910-13-P


MEMORANDUM

To:
Margaret Sheppard, U.S. EPA
CC:
Bella Maranion and Melissa Fiffer, U.S. EPA
From:
Jenny Tanphanich, Kara Altshuler, Reva Rubenstein, and Mark Wagner, ICF International
Date:
February 4, 2013
Re:
Review and Recommendation for Response to Adverse Comment on C7 Fluoroketone as a Halon 1211 Alternative (EPA Contract Number EP-W-10-031 Task Order 105, Task 01 and Task Order 205, Task 01)

This document does not contain Clean Air Act (CAA) Confidential Business Information (CBI) and, therefore, may be disclosed to the public.

ICF has reviewed comments specific to the proposed use of C7 FK as a streaming agent in EPA's Proposed Rule: Protection of Stratospheric Ozone:  Listing of Substitutes for Ozone-Depleting Substances  -  Fire  Suppression and Explosion Protection (September 2012). This memorandum summarizes ICF's responses to these comments and suggestions for future actions by the SNAP office.

The remainder of this memorandum is organized into the following sections:
   * Section 1: Introduction;
   * Section 2: Chemistry of C7 FK;
   * Section 3: Toxicity of C7 FK;
   * Section 4: Suggestions for Further Action; and
   * Section 5: References.

Please contact Kara Altshuler at<PHONE_NUMBER> or Mark Wagner at<PHONE_NUMBER> with any questions or comments.

1.  Introduction
In July of 2012, ICF submitted risk screens on the acceptability of use of C7 FK, submitted to the SNAP office by 3M, as a substitute for Halon 1211 in fire protection streaming applications.  The final risk screen discussed the atmospheric effects of the compound, including its global warming potential (GWP), ozone depletion potential (ODP), and atmospheric lifetime (ALT), and compared those parameters with Halon 1211 and two currently acceptable substitutes (i.e., HCFC-123 and HFC-236fa).  In addition, a discussion of the potential health effects of C7 FK was presented, which included exposure assessments for varying end users, such as occupational workers.  Health effects were evaluated via a review of available toxicity studies using animal models, and an acceptable exposure limit (AEL) for occupational workers was developed based on that review and using accepted risk assessment methodologies developed by EPA.  The decision by EPA that C7 FK was acceptable for use as a streaming agent was based in part on this risk screen.

EPA's Proposed Rule: Protection of Stratospheric Ozone: Listing of Substitutes for Ozone-Depleting Substances  -  Fire Suppression and Explosion Protection (September 2012) included C7 FK for use as a streaming agent.  A public comment posted in response to this proposed rule was made which questioned the potential toxicity of C7 FK based on the ability of some fluorinated ketones to react in the aqueous layer of human or animal tissues and exert toxicity.  The remainder of this memorandum addresses the supporting scientific literature and relevant background documents germane to assessing the raised concern of potential toxicity.
2.  Chemistry of C7 FK
C7 FK is a mixture of isomers with the following chemical formula, C7F14O:3-pentanone, 1,1,1,2,4,5,5,5-octafluoro-2,4-bis(trifluoromethyl) and 3-pentanone, 1, 1, 1, 2, 4, 4, 5, 5, 6, 6, 6-undecafluoro-2,4-bis(trifluoromethyl), with the octofluoro isomer representing 60% of the total mixture by weight (ICF 2012).

Ketones, starting with the simplest one (acetone), are susceptible to hydrolysis.  In the case of acetone, substitution of fluorines for hydrogens, giving hexafluoroacetone (HFA), makes the compound more electrophilic, shifting the equilibrium dramatically to one that favors formation of a gem-diol hydrate (equilibrium constant of 10[6] vs. 10[-3] with acetone).  This is because fluorine is highly electronegative, thereby making C-O bonds more susceptible to nucleophilic attack.  This characteristic for reactivity in halogenated ketones is cited by J.L. Adcock in a public comment in response to the proposed rule (Adcock 2012).  Adcock comments on the reactivity of C7 FK, and stresses the expected ability of its two main components (listed above) to react "...with water...to form a perfluorinated 'gem-diol' of low volatility, moderate acidity, and significant surface active behavior...."

Adcock provides two references to support this expectation of reactivity.  One of the references is Chapter VI of the textbook Aliphatic Fluorine Compounds (Lovelace et al. 1958) titled, Ketones, Aldehydes, and Acetals.  This chapter, however, focuses specifically on ways of creating fluorine-containing organic compounds, including ketones, and only says such fluorine-containing ketones have a "high percentage of enol content and they easily form stable hydrates."  Nothing more specific to the compound in question, such as stability or reactivity, is contained within.

The second reference, Gambaryan et al. (1966) also begins by discussing the vigorous reactivity of HFA with water or alcohols, resulting in a hydrate.  The article, however, is focused on the various fluoro-organic compounds that can be synthesized from perfluorinated compounds and discusses these methodologies in greater detail.  As these reactions often require harsh methods and solvents (e.g., heat, acids and bases, and organometallics), they are not relevant to the conditions in which C7 FK is proposed as a substitute for Halon 1211 in streaming applications.  The article provides no specific information regarding the reactivity or stability of C7 FK.  In summary, ICF found that both references documented the extreme reactivity of HFA in water, a fact that is supported by other sources of chemical information.  Adcock suggests that C7 FK is expected to react vigorously in water because HFA does so, but the recommended references provide no information to support that claim.

In the SNAP materials submitted for C7 FK in the streaming end-use (3M 2010a and 2010b) and more recent comments (Schultz 2012), 3M provided information that C7 FK has a very low solubility in water (estimates are on the order of <0.2 mg/mL) and a high Henry's Law Constant of 85,100 atm-m[3]/mole. These physical-chemical characteristics indicate that the compound, upon release to the environment, will be driven into the vapor phase, staying in the atmosphere and not partitioning or dissolving into surface water.

Very little information is available regarding the potential for hydrolysis of highly fluorinated compounds.  According to 3M, alpha-branched fluoroketones cannot easily form hydrate intermediates (e.g., gem-diols) as do smaller perfluorinated ketones, due to their structure and low water solubility (Schultz 2012).  This argument is supported by comparisons of carbon-hydrogen and carbon-fluorine bond lengths.  For example, the C-H bond length is 106-109 pm, while that of C-F is 133-142 pm.  According to Lewandowski et al. (2006), fluorine atoms "tightly screen a carbon chain" and make perfluorinated compounds highly resistant to hydrolysis, photolysis, microbial degradation, and metabolism by vertebrates.  In the case of C7 FK, the ketone group is shielded by the two -CF3 groups on either side of the oxygen atom, which indicates that this alpha-branched perfluoroketone will be similarly resistant to solubility in water (see Figure 2).

Figure 1.  Steric effects of  -- CH2 --  and  -- CF2 --  bonds (Taken from Lewandowski et al. 2006)

Figure 2.  2D Image of the octofluoro isomer of C7 FK (Taken from ChemSpider 2012)

Additional support for the hydrophobicity of C7 FK is provided by knowledge of the solvent dipolarity and polarizability of a compound, which measures the ability of a solvent to stabilize a charge or a dipole by virtue of its dielectric effect.  As evaluated by Kamlet et al. (1983), perfluoro-n-hexane has a dipolarity/polarizability value of -0.4, acetone has a value of 0.4, and water has a value of 1.09.  Although an imperfect surrogate for C7 FK, perfluoro-n-hexane is highly hydrophobic. C7 FK is likely to be highly hydrophobic as well, despite the presence of an internal ketone bond (as discussed earlier, the presence of so many fluorine atoms in C7 FK should shield the ketone bond from attack).  The lack of water solubility for C7 FK indicates that it will not form gem-diol hydrates and will thus not have appreciable effects in any organisms that might be exposed to it.
3.  Toxicity of C7 FK
In the comment to the Proposed Rule, Adcock indicates that the reactivity of perfluorinated ketones in water, particularly in tissues in which there is a lung:blood air interface (e.g., nose, sinus, trachea along an inhalation portal of entry) may pose significant risks to individuals breathing the compound due to interference with proper oxygenation of the blood and/or lung edema.  Such an effect would be evident in an animal toxicity test if it occurred.  Two inhalation studies were performed for C7 FK: a 5-day repeat toxicity study in which study animals were exposed to high concentrations of the compound, and a 28-day repeat dose study in which male and female rats were exposed to concentrations <=10,000 ppm for 6 hours per day.  The reported LC50 for the study was >10,000 ppm, the highest concentration used.  More importantly, no inhalation portal-of-entry effects were noted in either study.  No other observations were reported that might indicate any other adverse effects on blood oxygenation or similar impairments.  The recommended AEL for C7 FK is 225 ppm (ICF 2011), well below the 10,000 ppm high exposure concentration used in both studies. The animal toxicity data do not support the comment by J.L. Adcock that C7 FK is expected to react with water to form a stable gem-diol that will exhibit surface active behavior and thus may cause significant risk to individuals breathing the compound.
4. Suggestions for Further Action on C7 FK
ICF believes that C7 FK is acceptable for use as a streaming agent.  ICF does not believe that the AEL or risk screen documents need to be revised to respond to the comments to the proposed rule.  However, this response document can be used by EPA to further support its decision on this proposed end use for C7 FK.
5. References
3M. 2010a. SNAP Submission to EPA for C7 Fluoroketone. February 22, 2010.
3M. 2010b. P-10-135  -  C7 Fluoroketone Teleconference EPA/3M Summary. November 22, 2010.
Adcock JL. 2012.  Comment in response to the Proposed Rule: Protection of Stratospheric Ozone: Listing of Substitutes for Ozone-Depleting Substances  -  Fire Suppression and Explosion Protection. Document ID: EPA-HQ-OAR-2011-0111-0026. October 22, 2012.
ChemSpider. 2012.  Chemical information for 1,1,1,2,4,5,5,5-octafluoro-2,4-bis(trifluoromethyl)penan-3-one.  (Available at http://www.chemspider.com/Chemical-Structure.63134.html)
Gambaryan NP, Rokhlin EM, Zeifman YV et al. 1966.  Reactions of the carbonyl group in fluorinated ketones. Angew Chem Internat Edit 5(11):947-956.
ICF. 2011.  Determination of an Acceptable Exposure Limit for C7 Fluoroketone.  May 2011.
Kamlet MJ, Abbout J-L.M., Abraham MH et al. 1983.  Linear solvation energy relationships. 23. A comprehensive collection of the solvatochromic parameters, PI*, α, and ß, and some methods for simplifying the generalized solvatochromic equation.   J Org Chem 48:2877-2887.
Lewandowski G, Meissner E. et al. 2006.  Special applications of fluorinated organic compounds.  J Hazard Mater 136(3): 385-391.
Lovelace AM, Rausch DA, and Postelnek W. 1958. Chapter VI. Ketones, Aldehydes and Acetals. Aliphatic Fluorine Compounds. New York: Reinhold Publishing Corporation. pp. 180-187.
Schulz JF. 2012.  Comments in response to comment submitted by JL Adcock, in response to the Proposed Rule: Protection of Stratospheric Ozone: Listing of Substitutes for Ozone-Depleting Substances  -  Fire Suppression and Explosion Protection. November 30, 2012.


[Federal Register: March 14, 2008 (Volume 73, Number 51)]
[Notices]
[Page 13951-13952]
[DOCID:fr14mr08-123]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2005-22056]

Public Meeting: North American Cargo Securement Public Forum

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of public meeting.

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SUMMARY: FMCSA announces a public meeting concerning the implementation
of the North American Standard for Protection Against Shifting or
Falling Cargo. FMCSA's cargo securement rules are based on the North
American Cargo Securement Standard Model Regulations (Model
Regulations), reflecting the results of a multi-year comprehensive
research program to evaluate what were then current U.S. and Canadian
cargo securement regulations; the motor carrier industry's best
practices; and recommendations presented during a series of public
meetings involving U.S. and Canadian industry experts, Federal, State
and Provincial enforcement officials, and other interested parties.
Canada's Council of Ministers Responsible for Transportation and
Highway Safety approved a National Safety Code Standard for cargo
securement which is also based on the Model Regulations. This meeting
is to discuss the process for ensuring the consistent interpretation of
the harmonized cargo securement standards by FMCSA and the Canadian
Provinces, and interpretation issues raised by enforcement agencies and
motor carriers in the U.S. and Canada.

DATES: The meeting will be held on Wednesday, March 26, 2008. The
meeting will begin at 8 a.m. and end at 5 p.m.

ADDRESSES: The meeting will be held at the Colorado Convention Center,
700 14th Street, Denver, Colorado.

FOR FURTHER INFORMATION CONTACT: Mr. Mike Huntley, Chief of the Vehicle
and Roadside Operations Division (MC-PSV),<PHONE_NUMBER>, Federal
Motor Carrier Safety Administration, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

INFORMATION ON SERVICES FOR INDIVIDUALS WITH DISABILITIES: For
information on facilities or services for individuals with
disabilities, or to request special assistance at the meeting, contact:
Mr. Mike Huntley,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On September 27, 2002 (67 FR 61212), FMCSA published a final rule
revising its regulations concerning protection against shifting and
falling cargo for commercial motor vehicles operated in interstate
commerce. Motor carriers were given until January 1, 2004, to comply
with the new regulations.
    On September 23, 2004, Canada's Council of Ministers Responsible
for Transportation and Highway Safety approved a National Safety Code
Standard for cargo securement which is also based on the Model
Regulations. Full implementation of the new cargo securement
requirements in Canada began in the summer of 2005.
    On June 22, 2006 (71 FR 35819), FMCSA amended its cargo securement
rules in response to several petitions for reconsideration. The
amendments were effective on July 24, 2006.

Maintaining Uniformity Between U.S. and Canadian Cargo Securement
Standards

    FMCSA is committed to continuing to work with U.S. and Canadian
industry experts, Federal, State and Provincial enforcement officials,
and other interested parties to maintain, to the greatest extent
practicable, harmonization of U.S. and Canadian cargo securement
standards. A major part of this effort includes uniformity in
interpreting the meaning of the requirements adopted by the U.S. and
Canada. While there are some differences between certain provisions of
the regulations adopted by FMCSA and Canada's National Safety Code
Standard 10, most of the contents of the model regulations have been
adopted, or will soon be adopted, by almost all jurisdictions in the
U.S. and Canada. To ensure consistency in the interpretation and
enforcement of the requirements, FMCSA is working with its partners in
Canada to share information about requests for interpretation, and to
exchange technical information that would be helpful to the regulatory
agencies in developing responses to such requests. FMCSA is also
working with its partners in Canada to ensure that interpretations are
made available to all interested parties in an efficient and timely
manner.
    This meeting is intended to provide all stakeholders, including
motor carrier safety agencies and industry, with an opportunity to
discuss issues that have arisen concerning implementation of the cargo
securement regulations in both countries, and to promote safe,
harmonized requirements for the securement of cargo on or in commercial
motor vehicles throughout North America. Participation in the North
American Cargo Securement Forum is unrestricted, and open to all
stakeholders and interested persons, including motor carrier safety
enforcement agencies, safety advocacy groups, and industry.
    Meeting Information: The meeting will be held on Wednesday, March
26, 2008, at the Colorado Convention Center, 700 14th Street, Denver,
Colorado. The meeting will begin at 8 a.m. and end at 5 p.m. The
meeting is being held in connection with the Commercial Vehicle Safety
Alliance's (CVSA) 2008 Workshop. Attendance for the North American
Cargo Securement Public Forum is free of charge and open to all
interested parties. However, anyone interested in attending the
sessions and committee meetings of the CVSA's 2008 Workshop must
register with the CVSA and pay the appropriate registration fee. For
further information about registration for other sessions or meetings
of the CVSA's 2008 Workshop, please contact the CVSA at<PHONE_NUMBER>.

    Issued on: March 11, 2008.
Charles A. Horan III,
Acting Associate Administrator for Policy and Program Development.
[FR Doc. E8-5191 Filed 3-13-08; 8:45 am]

BILLING CODE 4910-EX-P


Summary of Petition

    The petitioner summary of the pesticide petition is printed below as
required by section 408(d)(3) of the FFDCA. The summary of the petition
was prepared by the petitioner and represent the views of the
petitioner. EPA is publishing the petition summary verbatim without
editing it in any way. The petition summary announces the availability
of a description of the analytical methods available to EPA for the
detection and measurement of the pesticide chemical residues or an

explanation of why no such method is needed.

Interregional Research Project Number 4 (IR-4)

PP 5E6979, 5E6980 and 5E6981

EPA has received a revision to pesticide petitions (5E6979, 5E6980 and
5E6981) from the Interregional Research Project #4 (IR-4), Rutgers, The
State University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540 proposing, pursuant to section 408(d) of the FFDCA,
21 U.S.C. 346a(d), to amend 40 CFR 180.511 by establishing a tolerance
for residues of buprofezin   ADVANCE \d4
(2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-
phenyl-4H-1,3,5-thiadiazin-4-one) in or on the following raw
agricultural commodities (RACs):

PP 5E6979 proposes the establishment of tolerances for stone fruit crop
group 12 (except peaches and nectarines) at 2.0 ppm.

PP 5E6980 proposes the establishment of tolerances for black sapote,
canistel, mamey sapote, mango, papaya, sapodilla, star apple, at 0.80
parts per million ppm (ppm).

      PP 5E6981 proposes an increase of  tolerance on grapes to 0.80
part per              million (ppm) and for raisins 1.2  parts per
million (ppm).

EPA has determined that the petition contains data or information
regarding

the elements set forth in section 408(d)(2) of the FFDCA; however, EPA
has not fully evaluated the sufficiency of the submitted data at this
time or whether the data supports granting of the petition. Additional
data may be needed before EPA rules on the petition.   Nichino America,
Inc. 4550 New Linden Hill Road Wilmington, DE 19808  is the registrant
for buprofezin with the EPA and prepared and submitted the following
summary of information, data, and arguments in support of the pesticide
petitions.  This summary does not necessarily reflect the findings of
the EPA.

A. Residue Chemistry

1.  Plant metabolism. The metabolic profile of buprofezin has been
elucidated in a wide range of crops, including tomatoes, lettuce,
cotton, and citrus.   In citrus, although buprofezin was a major
component of the residue, a chromatographically well-defined region of
radioactivity, clearly associated with polar conjugates, was observed.
Mass spectrometry identified the principal polar residue as a hexose
conjugate of BF4 (buprofezin hydroxylated in the t-butyl group).
Although the conjugate was resistant to enzyme hydrolysis, acid
hydrolysis of the polar fraction released predominantly BF26 with minor
amounts of BF9 and BF12. The same compounds were observed following acid
hydrolysis of a standard of BF4 clearly indicating that BF4 is the
conjugated metabolite existing in citrus. Although only limited
metabolism was observed in lettuce and cotton, trace levels of similar
metabolites, including the conjugate BF4 were observed indicating that
the metabolic pathway does not differ with plant species.

2.  Analytical method.  The proposed analytical method involves
extraction, partition, clean-up and detection of residues by gas
chromatography using  nitrogen phosphorous detection.  ADVANCE \d4

3.  Magnitude of residues-i. Plums. Six field trials on plums and
thirteen field trials on cherries were conducted.  The highest average
residue value for plums treated with buprofezin (HAFT) was 0.55 ppm, and
for cherries 1.32  ppm.  Dried plum samples had an average residue of
0.21 ppm, compared to a mean of 0.7 ppm in fresh plum from the same
trial, suggesting a 3X concentration factor and which would be covered
in the stone fruit crop group.  A tolerance of 2 ppm are being proposed
for the stone fruit crop group 12, except peaches, and are adequately
supported. ii.  Three field trials on papaya in Florida were conducted
to support a geographically-limited tolerance. The HAFT was 0.65 ppm
with the three day PHI.  A tolerance of 0.8 ppm is proposed for the
tolerance on papaya, star apple, black sapote, mango, sapodilla,
canistel, and mamey sapote are adequately supported. iii. Grapes. Field
trials on wine grapes and table grapes were conducted with buprofezin,
the principal residue of concern, in eight sites at the maximum rate,
applications, and the minimum preharvest interval of 7 days.  The
highest average residue value for grapes treated with buprofezin (HAFT)
was 0.70 ppm.  Using the EPA concentration factor of 1.5x, the residues
in raisins would be 1.05 ppm.  A tolerance of 0.8 ppm is proposed for
the tolerance on grapes and a tolerance of 1.2 ppm for raisins, and are
adequately supported.

B. Toxicological Profile

An extensive battery of toxicology studies has been conducted with
buprofezin.  An assessment of toxic effects caused by buprofezin is
discussed in the Federal Register of April 8, 2005 (70  FR 17901)
(FRL-7691-8).

1. Animal metabolism.  The metabolism of buprofezin has been extensively
studied in various species of animals and fish. Buprofezin has several
groups that can metabolize in a variety of ways thus potentially
producing a very large number of metabolites. Extensive metabolism to
many minor metabolites was observed in all the animal species.
Metabolism in fish was, however, much more limited and clearly defined.
Although not all metabolic intermediates have been detected in all the
species, the major routes of metabolism have been identified in animals
and fish and a consistent pattern is observed throughout these species.
The proposed metabolic pathway was provided in the tolerance petition,
PP 0F6087. For convenience, degradates are

referred to by an internal code: BF 1 through 13. Corresponding chemical
structures were provided in the tolerance petition, PP 0F6087.

i. Metabolism in rats.  The major metabolite found in rat excreta was
parent buprofezin in addition to several compounds formed after
extensive metabolism. Whereas plant metabolism appeared restricted
mainly to oxidation of the tertiary butyl group, oxidation of the butyl
group and hydroxylation of the phenyl ring were both observed in rats.
Oxidation of the t-butyl group proceeded beyond an alcohol to an acid
and was accompanied by ring opening. The most extensively metabolized
compound identified in rats was BF23 (acetylated p-aminophenol).

ii. Metabolism in ruminants and  hens. Residue levels were low (0.05
ppm) in all ruminant and poultry tissues and commodities, following
treatment at exaggerated rates (approximately 20x and 7,500x the
anticipated dietary burden, respectively). The only exceptions were cow
liver (1.21 ppm), cow kidney (0.41 ppm), hen liver (0.15 ppm), and egg
yolk (0.11 ppm). Extensive metabolism was observed in both species with
a large number of minor meta- bolites being produced.  The principal
metabolites identified in the cow were BF2 and BF23, indicating that the
major pathway of degradation in ruminants is hydroxylation of the phenyl
ring followed by opening and degradation of the heterocyclic ring. The
identification of trace levels of BF13 confirms this path-

way. As in rats, BF23 was the most extensively metabolized compound
identi- fied. Trace levels of BF12 were also detected. This indicates
that the parallel pathway of heterocyclic ring opening without
hydroxylation of the phenyl ring is also in operation. Similarly in
hens, the identified metabolites were derived from degradation of the
heterocyclic ring either with (BF13) or without (BF9 and BF12) phenyl
ring hydroxylation.  No single unidentified compound accounted for more
than 6% of the total residue in any animal tissue or commodity, with the
exception of a component comprising 8.7% of egg white. The total residue
in egg white was, however, only 0.02 ppm even at this highly exaggerated
dose rate.

 iii. Metabolism in fish. Analysis of fish tissues, following a
bioaccumu-lation study, found a much simpler metabolic profile.
Buprofezin was present in both edible and non-edible tissues, but the
principle metabolites were polar conjugates of BF4. Trace levels of BF12
were also detected.

2. Endocrine disruption. No special studies have been conducted to
investi-gate the potential of buprofezin to induce estrogenic or other
endocrine effects. The standard battery of required toxicity studies has
been completed. These studies include an evaluation of the potential
effects on reproduction and development and an evaluation of the
pathology of the endocrine organs following repeated or long-term
exposure. These studies are generally con- sidered to be sufficient to
detect any endocrine effects. The only effect noted on endocrine organs
was an increased incidence of follicular cell hypertrophy and C-cell
hyperplasia of the thyroid gland in rats administered buprofezin.
Buprofezin also caused mild to moderate hepatotoxic effects at this
dietary concentration.  The effect on the thyroid is consistent with an
increased turnover of T3/T4 in the liver with a resultant rise in TSH
secretion (due to the hepatotoxicity). The rat is known to be much more
susceptible than humans to these effects due to the very rapid turnover
of thyroxine in the blood in rats (12

hours vs. about 5-9 days in humans). Therefore, the thyroid pathological
 changes which have been noted following administration of high doses of
buprofezin are considered to be of minimal relevance to human risk
assessment, particularly considering the low levels of buprofezin to
which humans are likely to be exposed.

C. Aggregate Exposure

1. Dietary exposure.  Acute and chronic dietary risk analyses were
conducted to estimate to potential buprofezin residues in/on the
following crops: almonds, apricot, avocado, banana, canistel, cherry,
cotton, grape, grape raisin, longan, lychee, mango, papaya, mamey
sapote, Spanish lime, head lettuce, leaf lettuce, nectarine, plum,
prune, snap bean, tomato, cucurbit vegetables, citrus oil, citrus
orange, citrus grapefruit, citrus lemon, pistachio, pome fruit, apples,
pome fruit pear, and peach, and for animal kidney, fat, liver, meat, and
meat-by-products and milk,  using the Lifeline TM Version 3.0, which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity.

2. Food.  The acute dietary exposure was based on the following
assumptions: for all registered proposed commodities residues were at
tolerance levels, 100% crop treated, and EPA default  processing
factors,  with exceptions based on processing studies when available.
EPA had previously set the FQPA safety factor at 1X when assessing acute
and chronic dietary exposures.  The acute dietary aPAD (acute Population
Adjusted Dose) was set at 2.0 mg/kg/day for females aged 13-50 years old
based on a developmental toxicity study in rats that had an oral NOEL of
200 mg/kg/day and an FQPA safety factor (SF) of 1X.  The chronic dietary
cPAD (chronic Population Adjusted Dose) was determined to be 0.01
mg/kg/day for the general population based on a oral NOAEL of 1.0
mg/kg/day in the two-year rat chronic/oncogenicity study, and a FQPA
safety factor (SF) of 1X .  The uncertainty fact or of 100 was used to
account for interspecies and intraspecies variations.  Since the only
evidence of carcinogenicity was ‘suggestive’, this endpoint was not
deemed relevant to this assessment.

The resulting food exposure estimate for  females 13-49 years old was

6.13 % of the Population Adjusted Dose (aPAD) at the 95th percentile and
a MOE of 1630. Exposure to this subpopulation was estimated to be 0.123
mg/kg/day.  No acute endpoint was identified for the remaining
population subgroups. The acute exposure was based on tolerance level
exposures and assuming 100% of the crops were treated.

      The chronic dietary exposure was based on the following
assumptions:

% crop treated, maximum average values from the magnitude of the residue
studies for buprofezin for crops where the EPA had already established
tolerances and  crop tolerances for the new proposed tolerances for the
following crops: canistel, mango, papaya, sapodilla, mamey sapote,
grapes, apricots, cherry, nectarines, and plums.  In addition,
buprofezin conjugates were added to these values as specified in the EPA
Memorandum “Buprofezin-Acute and Chronic Dietary Exposure
Assessments”, dated 14 April-2004. Processing study concentration
factors were used when available and replaced the default values. The
food exposure estimates from residues of buprofezin  for the U.S.
population was 6.82 % and a MOE of 2360 of the chronic Population
Adjusted Dose (cPAD). Exposure to this subpopulation was estimated to be
0.000682 mg/kg/day.  The subpopulation with the highest exposure was
children 1-2 years old with 27.5 % of the cPAD used and a MOE of 464.
Exposure to this subpopulation was estimated to be 0.00275 mg/kg/day.
These are considered conservative values.

3.	Drinking water. The residue of concern in drinking water was
determined to be buprofezin.  There are no established maximum
contaminant levels or health advisory levels for residues of buprofezin
in drinking water.

In the absence of comprehensive water monitoring data, the Agency uses
the FQPA Index Reservoir Screening Tool or the Pesticide Root Zone

Model/Exposure Analysis Modeling System (PRZM/EXAMS) to produce
estimates of pesticide concentrations in an index resevoir.   The
SCI-GROW model is used to predict pesticide concentrations in shallow
ground water. For a screening-level assessment for surface water EPA
will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. Both FIRST and
PRZM/EXAMS incorporate an index reservoir environment, and both models
include a percent crop area factor as an adjustment to account for the
maximum percent crop coverage within a watershed or drainage basin.

    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.

  The estimated drinking water concentrations (EDWCs) in surface water
were estimated by the EPA in the Federal Register of April 8, 2005 the
Tier II PRZM (Pesticide Root Zone Model) and EXAMS (Exposure Analysis
Modeling Stystem (PE4-PL, version 01).  PRZM is used to simulate
pesticide transport as a result of runoff and erosion and spray drift
from an agricultural field and EXAMS estimates environmental fate and
transport of pesticides in surface water.  Based on the model outputs,
the estimated environmental concentrations (EECs ) for buprofezin are
4.5 parts per billion (ppb) for acute and chronic exposure to ground
water are 19.2 ppb and 4.5 ppb for acute and chronic exposure,
respectively to surface water .  The acute Drinking Water Level of
Concern (DWLOC) was calculated based on an acute Population Adjusted
Dose (aPAD) of 2.0 mg/kg/day.  For the acute assessment, the females
(13-49) subpopulation generated an acute DWLOC of 56,310  ppb.  The
acute DWLOC is considerably higher than the acute EEC of 19 ppb.
Chronic DWLOCs were calculated based on a chronic Population Adjusted
Dose (cPAD) of 0.01 mg/kg/day.   The children 1-2 years old
subpopulation generated the lowest chronic DWLOC of 72.5 ppb.  Thus, the
chronic DWLOC is higher than the chronic EEC of 4.5 ppb.

4. Non-Dietary Exposure

 ADVANCE \d4 The term residential exposure is used in this document to
refer to non-occupational, non-dietary exposure (e.g. for lawn and
garden pest control, indoor pest control, termiticides, and flea and
tick control on pets). Buprofezin is not registered for use on any sites
that would result in residential exposure.

D.  Cumulative Effects

A determination has not been made that buprofezin has a common mechanism
of toxicity with other substances. Buprofezin does not appear to produce
a common toxic metabolite with other substances. A cumulative risk
assessment was, therefore, not performed for this analysis. Cumulative
effects from substances with a common mechanism of toxicity. Section
408(b)(2)(D)(v) of FFDCA requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' Unlike other pesticides for which EPA
has followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
buprofezin and any other substances and buprofezin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has not assumed that
buprofezin has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's OPP
concerning common mechanism determinations and procedures for cumulating
effects from substances found to have a common mechanism on EPA's web
site at  ADVANCE \d4 http://www.epa.gov/ pesticides/cumulative/.

E. Safety Determination

1. U.S. Population-

i.  Acute risk.  Using the conservative assumptions discussed above,
based on the completeness and reliability of the toxicity data, it is
concluded that aggregate exposure to the proposed uses of buprofezin
will utilize at most

6.13 % of the acute reference dose of females (13-49) and is likely to
be much less, as more realistic data and models are developed.  EPA
generally has no concern for exposures below 100% of the aPAD  Drinking
Water Levels of Comparison (DWLOC) were calculated based on an aPAD of
2.0 mg/kg/day.  After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect the aggregate exposure
to exceed 100% of the aPAD.

ii. Chronic Risk.  Based on the toxicology data base and available
information on anticipated residues, the chronic dietary exposure to the
U.S. Population (total) was estimated as 0.000682 mg/kg/day and was 6.82
% of the estimated chronic population adjusted dose (cPAD).  Exposure to
potential residues in drinking water are expected to be negligible.
Based on these assessments, it can be concluded that there is reasonable
certainty of no harm to the U.S. Population or any population subgroup
from exposure to buprofezin.

2. Infants and children- Chronic exposure to children ages 1-2, the
highest exposed population subgroup, was 0.00275 mg/kg/day 27.5 % (of
the cPAD).  Exposure to potential residues in drinking water is expected
to be negligible.  EPA has determined that reliable data support using
the standard margin of exposure (MOE) and uncertainty factor (100 for
combined interspecies and intraspecies variability) for buprofezin and
that an additional safety factor of 10 is not necessary to be protective
of infants and children.  EPA generally has no concern for exposures
below 100% of the cPAD.  The acute EEC of 19 ppb is considerably less
than the DWLOC of 56,310 ppb.  For the chronic assessment, the children
1-2 years old subpopulation generated the lowest chronic DWLOC of
approximately 72.5 ppb.  For the general population, the chronic DWLOC
of  326 ppb is higher than the chronic EEC of 4.5 ppb.  The Agency has
considered the potential aggregate exposure from food, water and
non-occupational exposure routes and has concluded aggregate exposure is
not expected to exceed 100% of the chronic reference dose, and
consequently, has determined there is a reasonable certainty that no
harm will occur to infants and children from aggregate exposure to
residues of buprofezin.

F. International Tolerances

There are no Canadian or Mexican maximum residue limits (MRLs)
established for buprofezin in/on any of the commodities associated with
the current petition. There are Codex MRLs associated with cucumbers (1
ppm), oranges, sweet and sour (0.5 ppm),  and tomatoes (1 ppm).