Minimum Monitoring Requirements ICR Page i MINIMUM MONITORING REQUIREMENTS FOR DIRECT AND INDIRECT DISCHARGING MILLS IN THE BLEACHED PAPERGRADE KRAFT AND SODA SUBCATEGORY AND THE PAPERGRADE SULFITE SUBCATEGORY OF THE PULP, PAPER AND PAPERBOARD MANUFACTURING CATEGORY ( 40 CFR PART 430)

EPA ICR Number 1878.01 November 2001 U. S. Environmental Protection Agency Office of Water Engineering and Analysis Division 401 M Street, SW Washington, D. C. 20460 Minimum Monitoring Requirements ICR Page ii TABLE OF CONTENTS 1. IDENTIFICATION OF THE INFORMATION COLLECTION . . . . . . . . . . . . . . . . . . 1 1( a) Title of the Information Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1( b) Short Characterization/ Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. NEED FOR AND USE OF THE COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2( a) Need/ Authority for the Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2( b) Practical Utility/ Users of the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3( a) Non duplication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3( b) Public Notice Required Prior to ICR Submission . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( c) Consultations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( d) Effects of Less Frequent Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( e) General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3( f) Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3( g) Sensitive Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4. THE RESPONDENTS AND THE INFORMATION REQUESTED . . . . . . . . . . . . . . . 5 4( a) Respondents and SIC Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4( b) Information Requested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4( c) Recordkeeping Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 4( d) Respondent Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 5. THE INFORMATION COLLECTED AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT . . . . . . . . . . . . . . . . . . 11 5( a) Agency Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 5( b) Collection Methodology and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 5( c) Small Entity Flexibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 5( d) Collection Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION . . . . . . . . . . . . 12 6( a) Estimating Respondent Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6( b) Estimating Respondent Cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 6( c) Estimating Agency Burden and Cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 6( d) Estimating the Respondent Universe and Total Burden and Costs . . . . . . . . . . . . 22 6( e) Bottom Line Burden Hours and Cost Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 6( f) Burden Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Minimum Monitoring Requirements ICR Page iii LIST OF TABLES Table 4.1 Minimum Monitoring: Mill Respondent Requirements . . . . . . . . . . . . . . . . . . . . . . 6 Table 4.2 Reduced Effluent Monitoring for TCDD, TCDF, Chloroform, and the 12 Chlorinated Phenolics for Mills Participating in the Voluntary Advanced Technology Incentives Program ( VATIP) . . . . . . . . . . . . . . . 7 Table 4.3 Duration of Reduced Effluent Monitoring for TCDD, TCDF, Chloroform, and the 12 Chlorinated Phenolics for Mills Participating in the VATIP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Table 4.4 Reduced Effluent Monitoring for AOX for Mills Participating in the VATIP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Table 4.5 NPDES authorized State Requirements ( As Users of Data) . . . . . . . . . . . . . . . . . . 9 Table 4.6 State and Local Pretreatment Control Authorities Requirements ( As Users of Data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Table 6.1 Regulated Pollutants and Number of Affected Mills and Lines . . . . . . . . . . . . . . . 12 Table 6.2 Annual Sampling Burden for Subpart B Bleached Papergrade Kraft and Soda Mills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Table 6.3 Annual Sampling Burden for Subpart E Papergrade Sulfite Mills . . . . . . . . . . . . . 15 Table 6.4 Annual Reporting Burden for Each Pollutant . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Table 6.5 Annual Reporting Burden for Subpart B and E Mills . . . . . . . . . . . . . . . . . . . . . . 16 Table 6.6 Annual Recordkeeping Burden for Subpart B and E Mills . . . . . . . . . . . . . . . . . . 17 Table 6.7 Summary of Annual Respondent Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Table 6.8 Total Mill Respondent Capital Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Table 6.9 Analytical Sample Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Table 6.10 Annual ( O& M) Estimate of Analytical Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Table 6.11 Summary of Annual Agency Burden and Costs . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Table 6.12 Summary of Annual Respondent Burden and Costs . . . . . . . . . . . . . . . . . . . . . . . 23 Minimum Monitoring Requirements ICR Page iv LIST OF TABLES ( Continued)

Table 6.13 Total Estimated Annual Respondent Burden and Cost Summary ( 2000 Dollars) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Table 6.14 Total Estimated Annual Agency Burden and Cost Summary ( 2000 Dollars) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 LIST OF APPENDICES Appendix A: Supporting Assumptions and Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Minimum Monitoring Requirements ICR Page 1 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection ICR: Minimum Monitoring Requirements for Direct and Indirect Discharging Mills in the Bleached Papergrade Kraft and Soda Subcategory and the Papergrade Sulfite Subcategory of the Pulp, Paper, and Paperboard Point Source Category ( EPA ICR No. 1878.01).

1( b) Short Characterization/ Abstract This Information Collection Request ( ICR) presents estimates of the burden and costs to the regulated community and to the National Pollutant Discharge Elimination System ( NPDES) permit and pretreatment approval and control authorities for monitoring, reporting, recordkeeping, and follow up actions associated with implementation of the minimum monitoring requirements of the Pulp, Paper and Paperboard Effluent Limitations Guidelines and Standards ( Cluster Rules; 40 CFR Part 430), which were published on April 15, 1998 for mills in the Bleached Papergrade Kraft and Soda Subcategory ( Subpart B) and the Papergrade Sulfite Subcategory ( Subpart E). See 63 FR 18504 18751. The regulated community consists of approximately 94 direct and indirect discharging papergrade kraft, soda and papergrade sulfite mills.

The Cluster Rules establish minimum monitoring requirements for certain pollutants, namely adsorbable organic halides ( AOX), 2,3,7,8 tetrachlorodibenzo p dioxin ( TCDD), 2,3,7,8 tetrachlorodibenzofuran ( TCDF), chloroform and 12 chlorinated phenolics. Pursuant to the Paperwork Reduction Act, EPA intends to add these specific monitoring requirements contained in the Cluster Rules ( see 40 CFR § 430.02) to the ICR for NPDES/ Sewage Sludge Monitoring Reports ICR ( OMB 2040 0004) and the National Pretreatment Program ICR ( OMB 2040 0009). The current National Pretreatment Program ICR includes burden for indirect dischargers regulated under the Cluster Rules. This ICR serves to clarify and augment the burden already identified in the National Pretreatment Program ICR incurred by indirect dischargers for compliance with minimum monitoring requirements.

This ICR covers the minimum monitoring requirements for 94 direct and indirect discharging mills as well as the alternative requirements for those Subpart B mills that choose to enroll in the Voluntary Advanced Technology Incentives Program ( VATIP) until such time that these requirements are subsumed under the NPDES/ Sewage Sludge Monitoring Reports ICR ( OMB 2040 0004). This is a new ICR.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection As mentioned above, EPA established minimum monitoring frequencies for AOX, TCDD, TCDF, chloroform, and 12 chlorinated phenolics for existing and new direct and indirect discharging mills within Subparts B and E under authority of CWA Section 308. Discharge of Minimum Monitoring Requirements ICR Page 2 these pollutants into the freshwater, estuarine and marine ecosystems may alter aquatic habitats, affect aquatic life and adversely impact human health. Chlorinated organic compounds from chlorine bleaching, particularly TCDD and TCDF, are human carcinogens and human system toxicants and are extremely toxic to aquatic life. Additionally, Section 402( a)( 2) of the Clean Water Act ( CWA) directs EPA to prescribe permit conditions to assure compliance with requirements " including conditions on data and information collection, reporting and such other requirements as [ the Administrator] deems appropriate."

2( b) Practical Utility/ Users of the Data The primary users of the data are the owners and operators of direct and indirect discharging pulp and paper mills in Subparts B and E and NPDES permitting, pretreatment control, and enforcement authorities. Citizen groups also use this data to independently assess facility compliance.

EPA expects that the monitoring reports will be used by NPDES and pretreatment control authorities to determine compliance with the Cluster Rules effluent limitations and standards. EPA, States, and local authorities also analyze monitoring data when establishing permit and control agreement conditions and revise permit and pretreatment control agreement requirements based on data from monitoring reports. Furthermore, EPA and States refer to discharge monitoring reports and facility monitoring data on toxic pollutants when developing lists of waters not meeting applicable water quality standards. EPA anticipates that State NPDES permitting and pretreatment control authorities will only need to conduct detailed technical reviews of monitoring reports in the event the monitoring reports indicate noncompliance with the NPDES permit or pretreatment control agreement conditions.

EPA anticipates that permittees will use the monitoring data to track the effectiveness and progress of reducing pollutant discharges. For this reason, most permittees usually collect additional data ( e. g., product quality and production efficiency information) that may or may not be included with monitoring reports. Collection and reporting of data to permitting and pretreatment control authorities also provides permittees with an incentive to remain in compliance with their established permit limitations and conditions.

As public information, monitoring data is used by public environmental/ citizen groups for a variety of purposes. Citizen groups review monitoring data to independently assess discharger compliance. In some instances the data forms the basis for citizen suits that are authorized under Section 505 of the CWA. In addition, environmental groups, academicians and others use monitoring data to estimate pollutant loadings to streams, lakes, oceans and estuaries.

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non duplication Minimum Monitoring Requirements ICR Page 3 EPA has examined all other reporting requirements contained in the Clean Water Act and 40 CFR Parts 122, 123, 124, 125, 430, 501, and 503. The Agency also has consulted the following sources of information to determine if similar or duplicate information is available elsewhere:

° EPA Information Systems Inventory, ° Government Information Locator System ( GILS), and ° Toxic Chemical Release Inventory.

Examination of these databases revealed no duplicate collection requirements. Any monitoring requirements imposed by individual permits for the affected pollutants would be superseded by these requirements, unless they require more frequent monitoring than the Cluster Rules. EPA has concluded that there is no other way to obtain the compliance assessment information addressed in this ICR.

3( b) Public Notice Required Prior to ICR Submission EPA solicited comments on this ICR prior formal submission to OMB. EPA published a formal notice in the Federal Register on March 19, 2001 ( 66 FR 15424 15427). EPA received no comments.

3( c) Consultations EPA consulted with the public, industry and States on the minimum monitoring requirements through the rulemaking process for the Cluster Rules. As mentioned above, EPA received no comments on this ICR.

3( d) Effects of Less Frequent Data Collection EPA has determined the minimum monitoring frequencies established, at 40 CFR § 430.02( a) and ( b), are necessary to demonstrate compliance with the Cluster Rules' effluent limitations guidelines and standards. The regulation requires collection of daily, weekly, or monthly discharge data, depending on the pollutant. Some mill operators may collect such data independent of this requirement for purposes of monitoring and optimizing bleach plant, chemical recovery, and wastewater treatment plant operations. EPA determined that the minimum required monitoring frequencies were necessary because of the degree of change that is expected to occur to and temporal variability in pulping and bleaching processes and the resulting variations in effluent discharges of each fiber line that can and do occur frequently and at any time. Therefore, EPA was concerned that less frequent monitoring would not provide the information necessary to ensure compliance with the effluent limitations guidelines and standards promulgated as part of the Cluster Rules. See 63 Fed. Reg. at 18571 72.

In establishing the minimum monitoring frequencies for the regulated pollutants, EPA has struck a balance between the cost of the monitoring regimen and the need to ensure that sufficient data is consistently available to permitting and pretreatment control authorities. Permitting and Minimum Monitoring Requirements ICR Page 4 pretreatment control authorities need to have an adequate basis to verify compliance with the effluent limitations and standards given the environmental significance of these pollutants that are highly toxic and bioaccumulative, and the generation of which is variable as available data clearly demonstrate. This monitoring regimen also ensures sufficient data is available to the mill so that the mill may quickly become aware of and react to releases that may be harmful to the environment.

EPA selected a minimum monitoring frequency of once per month for TCDD, TCDF, and chlorinated phenolic pollutants. These pollutants are the most toxic and bioaccumulative among those regulated yet are also the most costly to analyze. EPA expects the 12 data points for each pollutant per year, together with daily end of pipe AOX data and information on process conditions from detailed mill logs, will yield a meaningful basis for establishing compliance with the promulgated effluent limitations and standards.

EPA selected a minimum monitoring frequency of once per week for chloroform. This monitoring frequency has been selected because data available indicates there can be considerable temporal variability of this pollutant in bleach plant wastewaters. This variability is attributable to a number of process and operational variables. Therefore, more data is required to adequately assess compliance with the limitations and standards on both a long term and short term basis. The cost of laboratory analysis of chloroform is much lower than for TCDD, TCDF, and chlorinated phenolics. Weekly data and information on process conditions from detailed mill logs will yield a meaningful basis for establishing long term compliance trends in chloroform discharge loadings and developing process control strategies to also ensure the short term compliance with the promulgated effluent limitations and standards.

EPA selected a minimum monitoring frequency of once daily for AOX for non TCF ( totally chlorine free) mills. This monitoring frequency has been selected because there can be considerable daily variability in chlorinated organic discharge loadings to receiving streams. Discharge loadings reflect bleach plant discharge patterns and secondary biological treatment system performance that is readily measured at reasonable cost. AOX analysis costs are anticipated to decrease as the number of mills ( in the respondent universe of this ICR) begin compliance monitoring efforts with the Cluster Rules. Daily monitoring for AOX provides a continuous data stream of all chlorinated organic constituents in wastewater, allowing mill operators and permit authorities to assess and control both process technologies and end of pipe biological treatment systems.

The minimum monitoring frequencies as described above will provide sufficient information to: ( 1) evaluate mill compliance with the Cluster Rules limitations and standards over the long term; and ( 2) allow permitting and pretreatment control authorities to judge whether a different frequency of monitoring is warranted after the initial compulsory period of minimum monitoring has been completed.

Additionally, EPA has offered Subpart B mills several options to reduce monitoring burden over the course of the permit cycle. These options include: Minimum Monitoring Requirements ICR Page 5

Enrollment in the VATIP, which was established by the Cluster Rules.

Certification in lieu of monitoring for chloroform ( proposed on April 15, 1998, 63 FR 18796).

Mills participating in the VATIP may be eligible for further reductions in monitoring requirements. See 40 CFR 430.02( c)( e). Mills enrolling in the VATIP are subject to more stringent BAT limitations and NSPS than EPA could otherwise compel through its minimum BAT and NSPS effluent limitations guidelines and standards. To encourage participation in the incentives program, EPA has provided for reduced monitoring requirements for participating mills. The reduced monitoring incentive applicable to AOX, TCDD, TCDF, chloroform and the 12 chlorinated phenolics is available as soon as participating mills achieve baseline BAT limitations, and for AOX after mills achieve the ultimate VATIP limitations ( see Table 4.2). See also 63 FR 18609 18610.

EPA has proposed a certification mechanism for Subpart B mills that demonstrate to the NPDES permitting authority that they have achieved the applicable limitations or standards for chloroform for a period of two years and that certain process and operating conditions are maintained. See 63 FR 18796 18802. Each mill voluntarily choosing to certify in lieu of monitoring for a fiber line would be required to maintain records documenting that process and operational conditions are maintained within the range established during the initial compliance demonstration. Following the required two year minimum monitoring period, mills would no longer be subject to minimum monitoring requirements for chloroform as required by 40 CFR § 430.02. As a result, the total monitoring burden would be reduced, if this proposed rule is promulgated by EPA.

3( e) General Guidelines This information collection is consistent with OMB guidelines contained in 5 CFR 1320.5( d)( 2).

3( f) Confidentiality EPA does not expect that confidential business information ( CBI) or trade secrets will be required from mill operators as part of this ICR. Where information submitted in conjunction with this ICR contains CBI, the respondent may request that this information be treated as confidential business information. All data so designated will be handled pursuant to 40 CFR Part 2 when EPA is the permitting or pretreatment control authority, and pursuant to applicable state rules and regulations governing CBI when states are the permitting or pretreatment control authorities. Pursuant to Section 308( b) of the Clean Water Act, effluent data may not be treated as confidential.

3( g) Sensitive Questions The reporting requirements addressed in this ICR do not include sensitive questions. Minimum Monitoring Requirements ICR Page 6 4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents and SIC Codes The respondent universe for this ICR will be: 1) approximately 94 direct and indirect discharging chemical pulp mills included in Subpart B ( Bleached Papergrade Kraft and Soda) and Subpart E ( Papergrade Sulfite) of the Pulp, Paper and Paperboard Manufacturing Category ( SIC 2611, 2631); and 2) the 23 NPDES and pretreatment approval authorized States and 10 local pretreatment control authorities responsible for ensuring compliance with NPDES and pretreatment regulations. Pretreatment approval authorities are defined as regulatory agencies, EPA or States, that oversee programs implemented by individual pretreatment control authorities ( i. e., publically owned treatment works ( POTWs)).

4( b) Information Requested The following sections outline the monitoring, reporting, and recordkeeping requirements for direct and indirect discharging facilities under 40 CFR 430. Table 4.1 outlines the information requirements for each category of respondents. The data requirements are listed by regulation number.

Table 4.1 Minimum Monitoring: Mill Respondent Requirements 40 CFR Citation Regulatory Description Monitoring and/ or Reporting Frequency Monitoring Requirements: Sample Collection and Analysis 430.02 ( a) For each non TCF ( Totally Chlorine Free) bleaching fiber line, mills must conduct minimum monitoring at the following frequencies: ° AOX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ° chloroform . . . . . . . . . . . . . . . . . . . . . . . . . . ° TCDD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ° TCDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ° each of the 12 chlorinated phenolics . . . . . . . . . Daily Weekly Monthly Monthly Monthly 430.54 ( a), 430.56 ( a) AOX limits are reserved for non TCF bleaching lines at direct and indirect Subpart E mills, therefore no minimum monitoring requirements for AOX exist for these mills.

430.02 ( a) There are no specified minimum monitoring frequencies for fiber lines with exclusively TCF bleaching. None 430.02 ( b) For direct dischargers, minimum monitoring frequencies apply for a duration of five years commencing on the date the applicable limitations or standards are first included in the discharger's NPDES permit. Minimum Monitoring Requirements ICR Page 7 Table 4.1 Minimum Monitoring: Mill Respondent Requirements 430.02( b) For existing indirect dischargers, minimum monitoring frequencies apply until April 17, 2006. For new indirect dischargers, minimum monitoring frequencies apply for a duration of five years commencing on the date the indirect discharger commences operation.

Reporting and Recording Requirements 122.41( l)( 4) Requires direct dischargers to report all monitoring results to the permitting authority using Discharge Monitoring Reports ( DMRs). Permit specific/ At Least Annually 122.44( i)( 2) 403.12 ( b), ( d), ( e), ( g) Requires indirect dischargers to report monitoring results to the pretreatment control authority using Periodic Compliance Reports ( PCRs). Agreement specific/ At Least Biannually 122.41( j)( 2) Requires direct dischargers to retain ongoing monitoring records and copies of all reports for at least 3 years from the date of the sample.

403.12( o)( 2) Requires indirect dischargers to retain ongoing monitoring records and copies of all reports for at least 3 years from the date of the sample.

Tables 4.2, 4.3 and 4.4 outline the reduced monitoring requirements for those mills enrolled in the VATIP.

Table 4.2 Reduced Effluent Monitoring for TCDD, TCDF, Chloroform, and the 12 Chlorinated Phenolics for Mills Participating in the Voluntary Advanced Technology Incentives Program ( VATIP)

40 CFR Reference Regulatory Description Monitoring Frequency 430.02( c) Requires non ECF1 Subpart B mills enrolled in the VATIP to conduct minimum monitoring for these pollutants at the following frequencies: ° chloroform . . . . . . . . . . . . . . . . . . . . . . . . . . . . ° TCDD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ° TCDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ° each of the 12 chlorinated phenolics . . . . . . . . Weekly Monthly Monthly Monthly 430.02( c) Requires Advanced ECF2 Subpart B mills enrolled in the VATIP to conduct minimum monitoring for these pollutants at the following frequencies: ° chloroform . . . . . . . . . . . . . . . . . . . . . . . . . . . . ° TCDD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ° TCDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ° each of the 12 chlorinated phenolics . . . . . . . . Monthly Monthly Monthly Monthly Minimum Monitoring Requirements ICR Page 8 Table 4.2 Reduced Effluent Monitoring for TCDD, TCDF, Chloroform, and the 12 Chlorinated Phenolics for Mills Participating in the Voluntary Advanced Technology Incentives Program ( VATIP)

430.02 ( c)( e) Subpart B mills enrolled in the VATIP that use exclusively TCF bleaching have no specified limits or monitoring frequencies for these pollutants. None Notes: 1 Non ECF pertains to any fiber line that does not use exclusively ECF or TCF bleaching processes. 2 Advanced ECF pertains to any fiber line that uses exclusively Advanced ECF bleaching processes, or exclusively ECF and TCF bleaching processes as disclosed by the discharger in its permit application under 40 CFR 122.21( g)( 3) and certified under 40 CFR 122.22.

Table 4.3 Duration of Reduced Effluent Monitoring for TCDD, TCDF, Chloroform, and the 12 Chlorinated Phenolics for Mills Participating in the VATIP 40 CFR Reference Regulatory Description Duration 430.02( c) The duration of monitoring is five years, commencing after achievement of the applicable VATIP limitations or standards for those pollutants.

Subpart B mills that certify that the fiber line uses Advanced ECF bleaching processes in their NPDES permit application or other communication to the permitting authority may discontinue monitoring at these frequencies after one year. The permitting authority will determine monitoring frequency beyond that time. 5 Years 1 Year Table 4.4 Reduced Effluent Monitoring for AOX for Mills Participating in the VATIP 40 CFR Reference Regulatory Description Monitoring Frequency 430.02 ( d) Subpart B mills enrolled in the VATIP may reduce monitoring frequencies for AOX for the first year after achievement of the applicable Stage 2 or ultimate VATIP limitations or standards for AOX, as follows: ° Non ECF  Tiers I, II, & III . . . . . . . . . . . . . . . . . . . ° Advanced ECF  Tiers I, II, & III . . . . . . . . . . . . . . ° TCF  Tiers I, II, & III . . . . . . . . . . . . . . . . . . . . . . . Daily Weekly None Minimum Monitoring Requirements ICR Page 9 Table 4.4 Reduced Effluent Monitoring for AOX for Mills Participating in the VATIP 430.02 ( e) Subpart B mills enrolled in the VATIP may reduce monitoring frequencies for AOX for years two through five after achievement of the applicable Stage 2 or ultimate VATIP limitations or standards for AOX, as follows: ° Non ECF  Tiers I, II, & III . . . . . . . . . . . . . . . . . . ° Advanced ECF  Tier I . . . . . . . . . . . . . . . . . . . ° Advanced ECF  Tier II . . . . . . . . . . . . . . . . . ° Advanced ECF  Tier III . . . . . . . . . . . . . . . . . ° TCF  Tiers I, II, & III . . . . . . . . . . . . . . . . . . . . . . Daily Monthly Quarterly Annually None Should a facility choose to collect and analyze more samples than specified in its permit, the permittee must include all monitoring data in the reports. See 40 CFR 122.41( j)( 4)( ii). As indicated in Table 4.1, submission of reports shall be at the frequency established by the NPDES permit or pretreatment control authority, but in no case less than once per year for direct dischargers and twice per year for indirect dischargers. Also, the permittee must collect and analyze representative samples and must conduct all monitoring requirements according to permit specific conditions and/ or approved test procedures as set forth under 40 CFR Parts 136, 430, and 503. See 40 CFR 122.41( j).

4( c) Recordkeeping requirements A sample of a pre printed discharge monitoring form may be obtained from the NPDES/ Sewage Sludge Monitoring Reports ICR. Direct and indirect dischargers are required to maintain monitoring records, copies of all reports required by the NPDES permit or pretreatment control agreement and records of all data used to complete the permit application for at least 3 years. See 40 CFR 122.41( j)( 2) and 40 CFR 403.12( o)( 2).

4( d) Respondent Activities ( i) Mill respondent activities include the following:

Preparing basic information. This includes reviewing regulatory and permit requirements; conducting monitoring; preparing chain of custody forms; coordinating with lab facilities; tracking of shipments; receipt and review of lab reports; preparation of DMRs or PCRs; and submitting reports to the NPDES permit or pretreatment control authority.

Maintaining records. All direct and indirect discharging mills in Subparts B and E must keep records of monitoring information and spill reports as required by the regulation. The burden for preparing spill reports and recordkeeping under 430.03( c)( 5) and ( g) is included in the Best Management Practices ICR ( ICR No. 1829.01; OMB No. 2040 0207), and thus is not accounted for in this ICR. Minimum Monitoring Requirements ICR Page 10 ( ii) NPDES and pretreatment approval authorized States and pretreatment control authorities respondent activities include:

° Discharge Monitoring Report ( DMR) and Periodic Compliance Report ( PCR) Review ° Follow up Activities ° Reporting and Recordkeeping Requirements Data review varies from State to State. Generally, the permitting and pretreatment control authority routinely screens data to identify permit violations and conducts a more thorough technical review and follow up when violations are detected. Follow up activities may include informal contact with the permittee ( by telephone or letter) requesting prompt corrective action, technical assistance, field inspections to further substantiate violations, in the case of indirect dischargers request assistance from the pretreatment approval authority, or a formal enforcement action such as an Administrative Order or referral to the EPA regional office and/ or the U. S. Attorney ( or State's Attorney General in the case of NPDES and pretreatment control authorized States). Table 4.5 summarizes NPDES authorized State requirements.

Table 4.5. NPDES authorized State Requirements ( As Users of Data)

40 CFR Citation Regulatory Description Response Frequency DMR data review § 123.26( a) Requires the NPDES permitting authority to have procedures for reviewing DMR submissions, using the reported data to evaluate permittee compliance. The permitting authority must also have procedures for conducting an initial screening of compliance related information. Variable/ Permit specific § 123.26( e) When warranted, requires the permitting authority to have procedures to follow up the initial screening with a substantive technical evaluation to determine permittee compliance with permit conditions. As Necessary Reporting and recordkeeping requirements § 123.26( e)( 4) Requires the permitting authority to have the procedures and ability for maintaining a management information system that supports the compliance evaluation activities. Ongoing Table 4.6 summarizes State and local pretreatment control authorities requirements.

Table 4.6. State and Local Pretreatment Control Authorities Requirements ( As Users of Data)

40 CFR Citation Regulatory Description Response Frequency PCR data review Minimum Monitoring Requirements ICR Page 11 § 403.8( f) Requires the pretreatment control authority to have procedures for reviewing PCR submissions, using the reported data to evaluate permittee compliance. The permitting authority must also have procedures for conducting an initial screening of compliance related information. Variable/ Permit specific § 403.8( f) When warranted, requires the pretreatment control authority to have procedures to follow up the initial screening with a substantive technical evaluation to determine permittee compliance with permit conditions. As Necessary Reporting and recordkeeping requirements § 403.8( f) Requires the pretreatment control authority to have the procedures and ability for maintaining a management information system that supports the compliance evaluation activities. Ongoing EPA anticipates that under 40 CFR § 403.8( f), the pretreatment control authority may request assistance from the pretreatment approval authority in its follow up activities to determine an indirect discharger's compliance with applicable pretreatment standards. Minimum Monitoring Requirements ICR Page 12 5. THE INFORMATION COLLECTED AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities Activities undertaken by EPA under this information collection primarily include oversight of the NPDES and pretreatment program, and where EPA is the NPDES permitting, pretreatment approval or control authority, review of monitoring data, and where necessary, follow up actions. Agency activities as the NPDES permitting or pretreatment control authority are essentially the same for NPDES authorized States summarized in Table 4.5 and State and local pretreatment control authorities summarized in Table 4.6.

The extent to which EPA reviews data in assessing permit compliance may vary. For example, EPA may conduct a more extensive review of permittees that are, or have been, in violation of their permit requirements, than of permittees who have been in full compliance. In cases of continued non compliance, EPA may use monitoring report data to identify patterns of non compliance and/ or to support Agency enforcement efforts. EPA and/ or the permitting authorities may limit its review of data submitted by fully compliant permittees to a simple determination of continuing compliance. After the initial period of minimum monitoring is complete, monitoring requirements may be reduced by the permitting authorities for permittees that consistently demonstrate an ability to reduce pollutants in their discharge below their permit limitations. EPA also expects, however, permitting authorities to consider whether poor performance, compliance or enforcement history, or other site specific factors indicate a need to impose more frequent monitoring than that specified in § 430.02. EPA may also review data from minor permittees that may cause water quality problems ( i. e, significant minors). EPA may review data from other minor permittees less frequently. In most cases, EPA will forward copies of reports to the States. EPA does not require the unauthorized States to review data, but several States voluntarily conduct the review and use the results in their own programs.

EPA regions may also review data from major direct and indirect discharging permittees while performing program oversight functions ( e. g., during file audits and when compiling statistical compliance summaries).

Reported data is often stored in the Permit Compliance System ( PCS) for reference. EPA and States may use this data to evaluate potential compliance problems, focus inspection efforts, conduct spot check reviews and determine appropriate enforcement action. PCS is available for public review at http:// www. epa. gov/ enviro/ html/ water. html# pcs.

5( b) Collection Methodology and Management Respondents typically report collected compliance data on DMRs and PCRs. Use of preprinted DMR and PCR forms is one method that EPA has used to improve its collection methodology. EPA has developed policy guidance for the electronic submission of data ( see 61 FR 46683 46694). The electronic submission of DMR/ PCR data is voluntary and will be an Minimum Monitoring Requirements ICR Page 13 alternative to the paper DMR/ PCR submission. EPA makes use of the PCS database to store, track and access this information.

5( c) Small Entity Flexibility EPA has certified that the Cluster Rules, including the minimum monitoring requirements will not have a significant economic impact on a substantial number of small entities. Only four mills are considered " a small business concern" as defined by SBA regulations. EPA does not believe this is a substantial number of small entities as that term is used in the RFA ( see Section X. C. of the Preamble to the final Cluster Rules published in the Federal Register on April 15,1998 ( see 63 FR 18611).

5( d) Collection Schedule The information collection activities included in this ICR are anticipated to coincide with existing reporting schedules. The timeframes for submitting compliance assessment information are outlined below:

° Monitoring and recordkeeping are performed on a continual basis ( see Table 4.1);

° Reports are to be prepared for submission to NPDES permit or pretreatment control authorities at a frequency to be determined by these authorities, but no less than once per year for direct dischargers or twice per year ( June and December) for indirect dischargers. EPA expects that such reporting frequencies will be consistent with existing reporting requirements already applicable to mills.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden This section describes the methods EPA used to estimate the burden to respondents associated with collecting, reporting and maintaining records of monitoring data. Although Subpart B mills may qualify for reduced monitoring frequencies by enrolling in the VATIP, EPA did not account for these possible reductions in order to estimate the full potential burden to Subpart B mills. The assumptions made and a brief description of the basis for the burden estimates are presented below. Further supporting calculations and assumptions may be found in Appendix A. The number of affected facilities and the pollutants regulated associated with this ICR are listed in Table 6.1 below. Minimum Monitoring Requirements ICR Page 14 Table 6.1 Regulated Pollutants and Number of Mills and Lines Category Number of Affected Direct Discharging Facilities Number of Affected Indirect Discharging Facilities Number of Bleach Lines Regulated Pollutants Direct Indirect Subpart B, Bleached Papergrade Kraft and Soda 75 9 120 14 AOX, TCDD, TCDF, chloroform, chlorinated phenolics Subpart E, Calcium/ Sodium/ Magnesium Sulfite 5 0 5 0 AOX Subpart E, Ammonium Sulfite 2 1 2 1 TCDD, TCDF, chlorinated phenolics Subpart E, Specialty Grade 2 0 2 0 TCDD, TCDF, chlorinated phenolics Total 84 10 129 15 ( i) Sampling Activities All Subpart B and E direct discharging mills will be required to monitor for new BAT and NSPS pollutants at the minimum frequency specified in 40 CFR 430.02 ( see Table 4.1). Direct discharging mills typically have one wastewater final effluent outfall with continuous monitoring capabilities. For AOX monitoring, which must be performed daily on the mill's final effluent, EPA anticipates that mill personnel will take an additional 15 minutes ( 0.25 hour) to prepare the AOX aliquot, labels and paperwork and to ship the sample to the laboratory for analysis.

All Subpart B and E indirect discharging mills will be required to monitor for new PSES and PSNS pollutants at the minimum frequency specified in 40 CFR 430.02 ( see Table 4.1). For indirect dischargers, AOX monitoring must be performed daily at the point where the wastewater containing that pollutant leaves the bleach plant. See 40 CFR 430.26( c) and 430.26( c). Some mills have a combined sewer containing both acidic and alkaline wastewaters, but most mills have bleach lines with separate acid and alkaline sewers, thus typically, there will be two monitoring stations per bleach line. These samples can be collected either automatically or manually. The samples can be either grab or composite. The bleach plant sampling burden is calculated assuming manual grab composite sampling:

Sampling Burden ( hours) = Avg. Number of Samples x Avg. Hours to Collect Sample When bleach acid and alkaline wastewater samples are collected separately, additional labor for flow proportioned composite sampling is anticipated ( see Appendix A, Section I for supporting assumptions and calculations). The labor required for daily monitoring for AOX for indirect Minimum Monitoring Requirements ICR Page 15 dischargers includes time to collect samples plus shipping of samples to the laboratory for analysis; this burden is estimated to be 30 minutes ( 0.5 hour) per sample.

For bleach plant monitoring, the Cluster Rules require all Subpart B and E mills to monitor for TCDD, TCDF, chloroform, and the 12 chlorinated phenolics at the point were the water containing these pollutants leaves the bleach plant. See 40 CFR 430.24( e), 430.25( e), 430.54( c) and 430.55( d). Some mills have a combined sewer containing both acidic and alkaline wastewaters, but most mills have bleach lines with separate acid and alkaline sewers, thus typically, there will be two monitoring stations per bleach line. These samples can be collected either automatically or manually. The samples can be either grab or composite. The bleach plant sampling burden is calculated assuming manual grab composite sampling:

Sampling Burden ( hours) = Avg. Number of Samples x Avg. Hours to Collect Sample When bleach acid and alkaline wastewater samples are collected separately, additional labor for flow proportioned composite sampling is anticipated ( see Appendix A, Section I for supporting assumptions and calculations). The labor required for monthly sampling for TCDD, TCDF and the 12 chlorinated phenolics includes time to collect samples plus shipping of samples to the laboratory for analysis; this burden is estimated to be 30 minutes ( 0.5 hour) per sample. For chloroform, however, separate samples and analyses of all bleach plant filtrates discharged separately are required to prevent the loss of chloroform either through air stripping as the samples are collected, measured, and composited or through chemical reaction when the acid and alkaline samples are combined. The labor required for weekly sampling of chloroform includes time to collect samples plus shipping of samples to the laboratory for analysis and is estimated to be 1.5 hours per sample. For Subpart B bleached papergrade kraft and soda mills, the annual sampling burden is summarized in Table 6.2. For Subpart E papergrade sulfite mills, the annual sampling burden is summarized in Table 6.3 ( see Appendix A, Section II for supporting assumptions and calculations).

Table 6.2 Annual Sampling Burden for Subpart B Bleached Papergrade Kraft and Soda Mills Pollutant Facilities Sampling Labor per sample ( hours) Sample frequency Total Annual Burden ( hours)

AOX ( Direct) 75 mills 1 final effluent 0.25 daily 6,844 AOX ( Indirect) 14 bleach lines 2 bleach plant 0.5 daily 5,110 AOX ( Indirect) 50 percent of 14 bleach lines flow proportioned composite 0.25 daily 639 chloroform 134 bleach plants 2 bleach plant 1.5 weekly 20,904 TCDD, TCDF, 12 chlorinated phenolics 134 bleach plants 2 bleach plant 0.5 monthly 1,608 Minimum Monitoring Requirements ICR Page 16 Table 6.2 Annual Sampling Burden for Subpart B Bleached Papergrade Kraft and Soda Mills TCDD, TCDF, 12 chlorinated phenolics 50 percent of 134 bleach lines flow proportioned composite 0.25 monthly 201 Total Sampling Burden for Subpart B mills ( hours) 35,306 Table 6.3 Annual Sampling Burden for Subpart E Papergrade Sulfite Mills Pollutant Facilities Sampling Labor per sample ( hours) Sample frequency Total Annual Burden ( hours)

AOX ( Direct) 5 calcium, magnesium, and sodium sulfite mills 1 final effluent 0.25 daily 456 TCDD, TCDF, 12 chlorinated phenolics 3 ammonium sulfite bleach lines 2 bleach plant 0.5 monthly 36 TCDD, TCDF, 12 chlorinated phenolics 2 specialty grade bleach lines 2 bleach plant 0.5 monthly 24 TCDD, TCDF, 12 chlorinated phenolics 50 percent of 5 bleach lines ( ammonium sulfite and specialty grade) flowproportioned composite 0.25 monthly 8 Total Sampling Burden for Subpart E mills ( hours) 524 ( ii) Analysis of Samples Collected samples are either analyzed on site using the facility's own laboratory or the samples are sent to an outside laboratory for analysis. For the purposes of this ICR, analysis burden is assumed to be contracted to outside laboratories for the purpose of estimating the full potential burden of minimum monitoring on Subpart B and E mills. This respondent burden is expressed as an " operation and maintenance" cost ( see Section 6( b), particularly Table 6.9).

( iii) Reporting and Recordkeeping Requirements Reporting of monitoring data involves compilation of data from various pollutant analyses and calculation of average pollutant concentrations and/ or loadings. The respondent records this information on the DMR or PCR and submits this information to the NPDES permitting or pretreatment control authority. For the purposes of this ICR, EPA assumed that DMRs and Minimum Monitoring Requirements ICR Page 17 PCRs are submitted monthly to the NPDES permit or pretreatment control authority in order to express the full potential reporting and recordkeeping costs associated with the minimum monitoring requirements for Subpart B and E mills. EPA estimates of the reporting burden per pollutant for the Cluster Rule effluent minimum monitoring are summarized in Table 6.4. Total annual reporting burden for Subpart B and E mills, using annual burden estimated per regulated pollutant as described in Table 6.4, is summarized in Table 6.5 ( see Appendix A, Section III for supporting assumptions and calculations).

Table 6.4 Annual Reporting Burden for Each Pollutant per Mill Pollutant Burden Assumptions Reporting Burden ( hours/ month) Annual Burden ( hours)

AOX daily results are averaged for monthly report 0.1 1.2 chloroform weekly reports averaged for monthly report 0.17 2.0 TCDD, TCDF, 12 chlorinated phenolics monthly reports at 2 minutes for each of 14 pollutants 0.47 5.6 Total 0.74 8.8 Table 6.5 Annual Reporting Burden for Subpart B and E Mills Category Regulated Pollutants Number of Affected Mills Annual Reporting Burden per mill ( hours) Total Annual Burden ( hours)

Subpart B, Bleached Papergrade Kraft and Soda AOX, TCDD, TCDF, chloroform, chlorinated phenolics 84 8.8 739 Subpart E, Calcium/ Sodium/ Magnesium Sulfite AOX 5 1.2 6 Subpart E, Ammonium Sulfite TCDD, TCDF, 12 chlorinated phenolics 3 5.6 17 Subpart E, Specialty Grade TCDD, TCDF, 12 chlorinated phenolics 2 5.6 11 Total Annual Reporting Burden for Subpart B and E mills ( hours) 773 Facilities that are required to submit monitoring data are also required to maintain records of that information. EPA assumes the time devoted to recordkeeping at these facilities generally involves copying and filing DMRs or PCRs. EPA estimates this burden to be 10 minutes ( 0.17 Minimum Monitoring Requirements ICR Page 18 hour) per DMR or PCR submitted with an extended amount of 40 minutes or 0.67 hour annually for quarterly reports for a total annual recordkeeping burden of 2.71 hours per mill. Total annual recordkeeping burden for Subpart B and E mills is summarized in Table 6.6.

Table 6.6 Annual Recordkeeping Burden for Subpart B and E Mills Category Number of Affected Facilities Annual Recordkeeping Burden per mill ( hours) Total Annual Burden ( hours)

Subpart B, Bleached Papergrade Kraft and Soda 84 2.71 228 Subpart E, Calcium/ Sodium/ Magnesium Sulfite 5 2.71 14 Subpart E, Ammonium Sulfite 3 2.71 8 Subpart E, Specialty Grade 2 2.71 5 Total Annual Recordkeeping Burden for Subpart B and E mill ( hours) 255 ( iv) NPDES authorized State Respondent Burden The burden and associated costs to NPDES authorized State permitting for processing and analyzing monitoring data are a function of: 1) the number of DMRs received by the permitting authority; 2) the time it takes to process and analyze monitoring data ( including entry into the PCS database); and, 3) the salary and associated overhead costs of the State employees who process DMRs. In addition to entering monitoring data into PCS, staff may need to conduct follow up actions in instances of non compliance. This follow up could be a phone conversation or a letter to verify, clarify or substantiate the information reported.

Of the 84 direct discharging mills in Subparts B and E, the States are authorized NPDES permit authorities for 74 mills. Compliance monitoring for the remaining 10 mills is overseen by EPA. Recurring incremental State burden for those that are authorized NPDES permit authorities for processing and analyzing monitoring data, including entry into the PCS database is estimated to be an average of 30 minutes ( 0.5 hour) per facility per DMR ( 74 mills x 12 DMRs per year) for an annual incremental burden of 444 hours. In addition, staff may need to conduct follow up actions in instances of non compliance. This follow up could be a phone conversation or a letter to verify, clarify or substantiate the information reported. EPA estimates that 20 percent of the DMRs submitted will require follow up action by the delegated States, particularly due to the unique nature of the new monitoring requirements imposed by the recently promulgated effluent limitations guidelines. EPA estimates that recurring incremental State burden for this follow up action requires an average of 30 minutes ( 0.5 hour) per facility per DMR or approximately 89 additional incremental hours per year for a total annual incremental burden of 533 hours.

( iv) State and Local Pretreatment Control Authority and State Pretreatment Approval Authority Respondent Burden Minimum Monitoring Requirements ICR Page 19 EPA estimates that the 10 indirect discharging mills in Subparts B and E are all regulated by local pretreatment control authorities, with States acting as pretreatment approval authorities for all ten mills. Recurring incremental burden for pretreatment control authorities for processing and analyzing monitoring data, including entry into the PCS database is estimated to be an average of 30 minutes ( 0.5 hour) per facility per PCR ( 10 mills x 12 PCRs per year) for an annual incremental burden of 60 hours. In addition, staff may need to conduct follow up actions in instances of non compliance. This follow up could be a phone conversation or a letter to verify, clarify or substantiate the information reported. EPA estimates that 20 percent of the PCRs submitted will require follow up action by the pretreatment control authorities with assistance by the pretreatment approval authority, particularly due to the unique nature of the new monitoring requirements imposed by the recently promulgated effluent limitations guidelines. EPA estimates that recurring incremental burden for this follow up action requires an average of 30 minutes ( 0.5 hour) per facility per PCR or approximately 12 additional incremental hours per year for a total annual incremental burden of 72 hours.

State pretreatment approval activities include program support, such as review of pretreatment control agreement renewal applications, and review of monitoring data ( 10 total mills). To estimate State pretreatment approval authority burden support activities, EPA assumes that approximately 20 percent of all PCRs submitted will require follow up assistance from State pretreatment approval authorities with an estimated burden of one hour per PCR for a total annual incremental burden of 24 hours.

A summary of annual respondent burden for Subpart B and Subpart E mills and States is presented in Table 6.7.

Table 6.7 Summary of Annual Respondent Burden Category Sampling Burden ( hours) Reporting Burden ( hours) Recordkeeping Burden ( hours) Total Annual Respondent Burden ( hours)

Subpart B, Bleached Papergrade Kraft and Soda 35,306 739 228 36,273 Subpart E, Calcium/ Sodium/ Magnesium Sulfite 456 6 14 476 Subpart E, Ammonium Sulfite 40 17 8 65 Subpart E, Specialty Grade 28 11 5 44 Totals for Subpart B and E mills 35,830 773 255 36,858 NPDES authorized States ° Processing and analyzing monitoring data............... ° Follow up actions for 20 percent of DMRs............................ 0 0 0 0 0 0 444 89 Minimum Monitoring Requirements ICR Page 20 Table 6.7 Summary of Annual Respondent Burden Totals for State NPDES Authorities 0 0 0 533 Local Pretreatment Control Authorities ° Processing and analyzing monitoring data............... ° Follow up actions for 20 percent of PCRs............................ 0 0 0 0 0 0 60 12 Totals for Local Pretreatment Control Authorities 0 0 0 72 State Pretreatment Approval Authorities ° Follow up actions for 20 percent of PCRs............................ 0 0 0 24 Totals for State Pretreatment Approval Authorities 0 0 0 24 Totals for all Respondents 37,473 6( b) Estimating Respondent Cost EPA evaluated the total cost for each respondent activity based on the following three cost items:

° Labor Costs ° Capital/ Start up Cost ° Operations and Maintenance ( O& M) Costs ( i) Estimating Labor Costs ( 2000 Dollars)

Estimates for respondent labor costs were prepared using industry specific labor rates identical to those used for the BAT Cost Model ( in 1995 dollars; see BAT Cost Model Support Document, DCN 13953), which included overhead and fringe benefits, and adjusted with the Consumer Price Index to 2000 dollars:

Technician $ 56.91 / hour Operator $ 28.91 / hour Technician labor is applied to reporting and recordkeeping burdens. Operator labor is applied to sampling burden.

Estimates for Federal and State labor rates were based on the 1998 US Labor department figures adjusted to 2000 dollars with the Consumer Price Index, whereby the average annual salary for Federal and State employees is $ 43,926; this is equivalent to the salary of a GS 9, Step Minimum Monitoring Requirements ICR Page 21 10 Federal employee. At 2,080 available labor hours per year, the hourly rate is $ 21.12. Overhead costs for Federal and State employees are estimated by EPA to be 60 percent ( EPA ICR Handbook), or $ 12.67 per hour, which results in a total hourly rate of $ 33.79 ($ 21.12 + $ 12.67).

Estimates for local pretreatment control authority employees ( i. e., POTW employees) were based on the 2000 US Labor department figures for the wages and salaries value for State and local government workers plus a 50 percent overhead burden; this is equivalent to an hourly rate of $ 30.86 ($ 20.57 + $ 10.29).

( ii) Estimating Capital/ Start up Costs The anticipated capital costs associated with this ICR comprise installing bleach plant effluent flow monitoring stations, which includes:

flowmeters for bleach plant flow measurements

bleach plant chloroform sampling train

composite samplers for required bleach plant monitoring ° sample point installation EPA estimated costs for two monitoring stations per bleach line, assuming one acid stage filtrate and one alkaline stage filtrate, in order to express the full potential capital costs of minimum monitoring on Subpart B and E mills. EPA assumed that end of pipe monitoring stations are already in place at all Subpart B and E mills. Therefore, no capital costs are associated with final effluent minimum monitoring. Total capital costs for the installation of bleach plant effluent flow monitoring stations were estimated to be $ 128,210 ( 2000 dollars) per bleach plant. This cost was based on an October 29, 1993 memorandum entitled " Bleach Plant Flow Monitoring Station Costs,' found in the Record for the Rulemaking and Section <IP_ADDRESS> of the BAT Cost Model Support Document ( DCN 13953, June 1996), adjusted to 2000 dollars with the Marshall and Swift Equipment Costs Index.

Table 6.8 Total Mill Respondent Capital Costs Category Number of Bleach Lines Total Capital Cost ( 2000 Dollars)

Subpart B, Bleached Papergrade Kraft and Soda 134 $ 17,180,140 Subpart E, Calcium/ Sodium/ Magnesium Sulfite 5 $ 641,050 Subpart E, Ammonium Sulfite 3 $ 384,630 Subpart E, Specialty Grade 2 $ 256,420 Total 144 $ 18,462,240 ( iii) Operations and Maintenance ( O& M) Costs Minimum Monitoring Requirements ICR Page 22 To estimate O& M costs associated with this ICR, EPA assumes that mills would send their collected samples to outside laboratories for analysis. Some facilities may perform in house analysis for some pollutants ( e. g., AOX and/ or chloroform). However, for the purposes of this ICR, EPA assumed that all analyses will be contracted to outside laboratories in order to express the full potential analytical costs of minimum monitoring on Subpart B and E mills. In the future, facilities may elect to conduct analysis in house, particularly AOX analyses, since the monitoring requirement is daily.

Analytical costs performed at outside laboratories were taken from the BAT cost model in the " BAT Cost Model Support Document" ( DCN 13953) and adjusted with the Consumer Price Index to 2000 dollars. These costs are as follows:

Table 6.9 Analytical Sample Costs Analyte Cost/ sample ( 2000 dollars)

AOX 130 TCDD / TCDF 948 chlorinated phenolics 541 chloroform 292 Table 6.10 shows the cost of sampling analysis for contracted lab work ( see Appendix A for supporting assumptions and calculations).

Table 6.10 Annual ( O& M) Estimate of Analytical Costs1 Affected Category Sampling Parameter Analyses/ year Cost ( 2000 dollars)

Subpart B: bleached papergrade kraft and soda mills AOX2 TCDD/ TCDF2 chlorinated phenolics2 chloroform 35,040 2,412 2,412 13,936 4,555,200 2,286,576 1,304,892 4,069,312 Total Analytical Costs for Subpart B mills $ 12,215,980 Subpart E: papergrade sulfite AOX ( calcium only) 2 TCDD/ TCDF2 chlorinated phenolics2 1825 90 90 237,250 85,320 48,690 Total Analytical Costs for Subpart E mills $ 371,260 Total Analytical Costs for Subpart B and E mills $ 12,587,240 Notes: 1 Costs presented assume that all analytical work is contracted to outside laboratories. Minimum Monitoring Requirements ICR Page 23 2 Analyses/ year reflect that 50 percent of bleach lines will use one flow proportioned composite for analysis in lieu of two separate bleach plant samples ( see Appendix A)

6( c) Estimating Agency Burden and Cost The estimates of EPA burden for direct dischargers are based on management and support activities for mills located in:

States without NPDES authority: EPA activities include analysis of monitoring data and review of DMRs ( 10 total mills); this would translate to an incremental burden in addition to current activities. Recurring incremental EPA burden for processing and analyzing monitoring data, including entry into the PCS database ( reporting and recordkeeping), is estimated to be 30 minutes ( 0.5 hour) per facility per DMR. In addition, EPA assumes that approximately 20 percent of all DMRs submitted will require follow up action ( as was assumed in Section 6( a)( iv)), with an estimated burden of one hour per DMR.

States with NPDES authority: EPA activities include program support, such as review of NPDES permit renewal applications and draft permits, and review of monitoring data ( 74 total mills). To estimate Agency burden support activities, EPA assumes that approximately 20 percent of all DMRs submitted will require follow up assistance from EPA with an estimated burden of one hour per DMR.

The estimates of EPA burden for indirect dischargers are based on management and support activities for mills located in States acting as the pretreatment approval authority. EPA activities include program support, such as review of pretreatment agreement renewal applications and draft permits, and review of monitoring data ( 10 total mills). To estimate Agency burden support activities, EPA assumes that approximately 20 percent of all PCRs submitted will require followup assistance from EPA with an estimated burden of one hour per PCR.

Table 6.11 Summary of Annual Agency Burden and Costs Category Affected Subpart B and E Mills Activity Annual Labor Hours Annual Costs ( 2000 Dollars)

Agency Burden Associated with Direct Dischargers States without NPDES Permit Authority 10 Processing and analyzing monitoring data Follow up actions for 20 percent of DMRs 60 24 $ 2,030 $ 810 States with NPDES Permit Authority 74 Follow up actions for 20 percent of DMRs 178 $ 6,010 Agency Burden Associated with Indirect Dischargers Minimum Monitoring Requirements ICR Page 24 Table 6.11 Summary of Annual Agency Burden and Costs Category Affected Subpart B and E Mills Activity Annual Labor Hours Annual Costs ( 2000 Dollars)

States with Pretreatment Approval Authority 10 Follow up actions for 20 percent of PCRs 24 $ 810 Total Annual Agency Burden and Costs 94  286 $ 9,660 6( d) Estimating the Respondent Universe and Total Burden and Costs Table 6.12 summarizes the total annual industry burden and costs inclusive of the sampling, analysis, reporting and recordkeeping burden and annual burden and costs to State NPDES permitting authorities. Minimum Monitoring Requirements ICR Page 25 Table 6.12 Summary of Annual Respondent Burden and Costs Category Annual Labor Hours Annual Costs ( 2000 Dollars)

Respondents  Sampling Burden Subpart B, Kraft & Soda Mills . . . . . . . . . . . . . . . Subpart E, Sulfite Mills . .. . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35,306 524 35,830 1,020,700 15,150 $ 1,035,850 Respondents  Analytical Costs Subpart B, Kraft & Soda Mills . . . . . . . . . . . . . . . Subpart E, Sulfite Mills . .. . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .    12,215,980 371,260 $ 12,587,240 Respondents  Reporting Burden Subpart B, Kraft & Soda Mills . . . . . . . . . . . . . . . Subpart E, Sulfite Mills . .. . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 739 34 773 42,060 1,940 $ 44,000 Respondents  Recordkeeping Burden Subpart B, Kraft & Soda Mills . . . . . . . . . . . . . . . Subpart E, Sulfite Mills . .. . . . . . . . . . . . . . . . . . . Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228 27 255 12,980 1,540 $ 14,520 Respondents  Subpart B and E mills 36,858 $ 13,681,610 Respondents  State NPDES Authorities 533 $ 18,010 Respondents  State Pretreatment Approval Authorities 24 $ 810 Respondents  Local Pretreatment Control Authorities 72 $ 2220 Total Annual Respondent Burden and Cost 37,487 $ 13,702,650 6( e) Bottom Line Burden Hours and Cost Tables The bottom line burden hours and cost tables for respondents are the summaries of all the hours and costs incurred for all activities.

( i) Respondent Tally The bottom line respondent burden ( affected facilities and local and State authorities) is presented in Table 6.13. Total annualized capital cost for Subpart B and E mills was estimated using the formula for Annualized Net Present Value with a discount rate of 7.0 percent and a timeframe of three years, equal to the duration of minimum monitoring required by this ICR. Minimum Monitoring Requirements ICR Page 26 Table 6.13 Total Estimated Annual Respondent Burden and Cost Summary ( 2000 Dollars)

Category Number of Respondents Total Hours Per Year Total Labor Cost Per Year Total Annualized Capital Costs Total Annual O& M Costs ( analytical costs)

Respondents  Subpart B and E mills 94 36,858 $ 1,094,370 $ 6,414,910 $ 12,587,240 Respondents  Local and State authorities 33 629 $ 21,040 $ 0 $ 0 Total Respondents 127 37,487 $ 1,115,410 $ 6,414,910 $ 12,587,240 ( ii) The Agency Tally The bottom line Agency tally is presented in Table 6.14 ( see supporting assumptions in Section 6( c)).

Table 6.14 Total Estimated Annual Agency Burden and Cost Summary ( 2000 Dollars)

Category Total Hours Per Year Total Labor Cost Per Year Total Annualized Capital Costs Total Annual O & M Costs Agency 286 $ 9,660 $ 0 $ 0 6( f) Burden Statement EPA estimates that there are 94 affected mills ( direct and indirect dischargers) in Subpart B and Subpart E of the Pulp, Paper and Paperboard Point Source Category with a total of 144 bleach lines. These mills will perform the additional sample collection and pollutant analyses; reporting and recordkeeping to permit and pretreatment authorities, as part of NPDES permit and pretreatment control requirements, will not change significantly from existing conditions. EPA estimates affected mills to incur a burden of 35,830 hours per year for sample collection, corresponding to a cost of $ 1,035,850. Capital costs estimated for the minimum monitoring requirements include the installation of bleach plant monitoring stations, resulting in an annualized capital cost of $ 6,414,910 for all mill respondents. Contracted laboratories are anticipated to perform all required analyses of collected samples for minimum monitoring with an estimated O& M cost for all mill respondents of $ 12,587,240. Annual reporting burden incurred by affected facilities is estimated to be 773 hours for a cost of $ 44,000, and annual recordkeeping burden is estimated to be 255 hours for a cost of $ 14,520 per year. Total mill respondent burden for the minimum monitoring requirements is estimated to be 36,858 labor hours at a cost of $ 20,096,520 ($ 1,035,850 + $ 6,414,910 + $ 12,587,240 + $ 44,000 + $ 14,520). On a per facility basis, mills are anticipated to incur an average of 400 hours per year for sampling, reporting and recordkeeping for monthly DMRs or PCRs for an average annual cost of $ 213,790, including capital and O& M costs. Minimum Monitoring Requirements ICR Page 27 NPDES authorized States are estimated to incur 533 burden hours for processing and analyzing monitoring data captured in submitted DMRs and for follow up activities associated with 20 percent of all DMRs submitted. This hourly burden translates to an estimated $ 18,010 annually for these activities.

Local pretreatment control authorities are estimated to incur 72 burden hours for processing and analyzing monitoring data captured in submitted PCRs and for follow up activities associated with 20 percent of all PCRs submitted. This hourly burden translates to an estimated $ 2,220 annually for these activities. State pretreatment approval authorities are estimated to incur 24 burden hours per year for support of local follow up activities at a cost of $ 810.

EPA burden is estimated to be 286 hours per year for support of State follow up activities as well as acting as the NPDES permit authority for 10 mills where the States are not authorized NPDES authorities at a cost of $ 9,660.

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 the use of automated collection techniques to Don Anderson, U. S. Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania Avenue N. W. ( 4303), Washington, D. C. 20460. Include the EPA ICR number 1878.01 in any correspondence. Minimum Monitoring Requirements ICR Page 28 Appendix A: Supporting Assumptions and Calculations I. Flow Proportioned Composite Sampling The Preamble to the Cluster Rules specifies " For dioxin, furan, and chlorinated phenolic compounds, compliance with the effluent limitations and standards can be demonstrated by collecting separate samples of the acid and alkaline discharges and preparing a flow proportioned composite of these samples, resulting in one sample of bleach plant effluent for analysis". See 63 FR 18569.

To prepare a flow proportioned composite, the operator: 1) must know the flow in each sampled sewer; 2) add them together to estimate total flow; and 3) calculate the proportion of the flow attributable to each sewer. Knowing the total volume of sample required for analysis, the operator must then: 1) calculate the volume of sample from each sewer that should make up the total sample volume; 2) measure out each volume; and 3) combine and mix them together. This mixture is then dispensed into the sample containers and sent to the laboratories for analysis.

It is assumed that for 50 percent of the bleach lines, flow proportioned composites will be prepared, requiring 15 minutes of operator labor. For these bleach lines there will be one instead of two samples to be analyzed for AOX, TCDD, TCDF, and the 12 chlorinated phenolic compounds.

II. Example of Total Sampling Burden calculation:

Refer to Tables 6.2 and 6.3 Assuming a manual grab composite methodology is used for TCDD, TCDF and the 12 chlorinated phenolics, the labor requirement may be estimated as follows:

5 minutes/ point/ grab x 6 grabs/ sample = 30 minutes/ point/ sample Assuming a manual grab composite methodology is used for chloroform, the labor requirement may be estimated as follows:

15 minutes/ point / grab x 6 grabs/ sample = 90 minutes/ sample For Subpart B mills, the annual sampling burden is:

Daily AOX sampling of final effluent ( direct dischargers): 75 mills x 1 final effluent discharge/ mill x 0.25 hours/ day x 365 day/ year = 6,844 hours Daily AOX sampling of bleach plants ( indirect dischargers): 14 bleach lines x 2 sample/ bleach line x 0.5 hours/ day x 365 day/ year = 5,110 hours Monthly flow proportioned composites for AOX ( indirect dischargers): Minimum Monitoring Requirements ICR Page 29 50 percent of 14 bleach lines x 0.25 hours/ day x 365 days/ year = 639 hours Weekly chloroform sampling at bleach plant: 134 bleach lines x 2 sample/ bleach line x 1.5 hours/ week x 52 weeks/ year = 20,904 hours Monthly TCDD, TCDF and the 12 chlorinated phenolics sampling at the bleach plant: 134 bleach lines x 2 sample/ bleach line x 0.5 hours/ month x 12 months/ year = 1,608 hours Monthly flow proportioned composites for TCDD, TCDF and the 12 chlorinated phenolics: 50 percent of 134 bleach lines x 0.25 hours/ month x 12 months/ year = 201 hours TOTAL ANNUAL SAMPLING BURDEN FOR SUBPART B MILLS 35,306 For Subpart E mills, the annual sampling burden is:

Daily AOX sampling of final effluent ( direct dischargers): 5 mills x 1 final effluent discharge/ mill x 0.25 hours/ day x 365 day/ year = 456 hours Monthly TCDD, TCDF and the 12 chlorinated phenolics sampling at the bleach plant ( Ammonium sulfite bleach lines): 3bleach lines x 2 sample/ bleach line x 0.5 hours/ month x 12 months/ year = 36 hours Monthly TCDD, TCDF and the 12 chlorinated phenolics sampling at the bleach plant ( Specialty grade bleach lines): 2 bleach lines x 2 sample/ bleach line x 0.5 hours/ month x 12 months/ year = 24 hours Monthly flow proportioned composites for TCDD, TCDF and the 12 chlorinated phenolics ( Ammonium sulfite and Specialty grade lines) 50 percent of 5 bleach lines x 0.25 hours/ month x 12 months/ year = 8 hours TOTAL ANNUAL SAMPLING BURDEN FOR SUBPART E MILLS 524 hours III. Example of Total Reporting and Recordkeeping Burden calculation:

Refer to Tables 6.5 and 6.6 For Subpart B mills, the annual reporting and recordkeeping burden is:

Annual Reporting burden: 84 mills x 8.8 hours = 739 hours Minimum Monitoring Requirements ICR Page 30 Annual Recordkeeping burden: 84 mills x 0.17 hours/ DMR x 12 DMRs + 84 mills x 0.67 hours/ quarterly reports = 228 hours TOTAL ANNUAL REPORTING AND RECORDKEEPING BURDEN FOR SUBPART B MILLS 967 hours For Subpart E mills, the annual reporting and recordkeeping burden is:

Annual Reporting burden: 5 Calcium/ Sodium/ Magnesium Sulfite mills x 1.2 hours = 6 hours 3 Ammonium Sulfite mills x 5.6 hours = 17 hours 2 Specialty Grade mills x 5.6 hours = 11 hours Annual Recordkeeping burden: 5 Calcium/ Sodium/ Magnesium Sulfite mills x 0.17 hours/ DMR x 12 DMRs + 5 Calcium/ Sodium/ Magnesium Sulfite mills x 0.67 hours/ quarterly reports = 14 hours 3 Ammonium Sulfite mills x 0.17 hours/ DMR x 12 DMRs + 3 Ammonium Sulfite mills x 0.67 hours/ quarterly reports = 8 hours 2 Specialty Grade mills x 0.17 hours/ DMR x 12 DMRs + 2 Specialty Grade mills x 0.67 hours/ quarterly reports = 5 hours TOTAL ANNUAL REPORTING AND RECORDKEEPING BURDEN FOR SUBPART E MILLS 61 hours IV. Example of TCDD, TCDF and 12 Chlorinated Phenolics Analyses per Year calculation:

Refer to Table 6.10 For Subpart B mills, the analyses per year for TCDD, TCDF and 12 Chlorinated Phenolics is:

Flow proportional composite ( derived from 2 bleach plant samples per month per bleach line) analysis:

50 percent of 134 bleach lines x 12 composites/ year = 804 analyses Bleach plant sampling ( portion of Subpart B mills not conducting flow proportioned composites) analysis:

50 percent of 134 bleach lines x 2 samples/ month x 12 months/ year = 1,608 analyses TOTAL TCDD, TCDF AND 12 CHLORINATED PHENOLICS Minimum Monitoring Requirements ICR Page 31 ANALYSES PER YEAR FOR SUBPART B MILLS 2,412 analyses For Subpart E mills, the analyses per year for TCDD, TCDF and 12 Chlorinated Phenolics is:

Flow proportional composite ( derived from 2 bleach plant samples per month per bleach line) analysis:

50 percent of 5 bleach lines ( Ammonium Sulfite and Specialty Grade) x 12 composites/ year = 30 analyses Bleach plant sampling ( portion of Subpart E mills not conducting flow proportioned composites) analysis:

50 percent of 5 bleach lines ( Ammonium Sulfite and Specialty Grade) x 2 samples/ month x 12 months/ year = 60 analyses TOTAL TCDD, TCDF AND 12 CHLORINATED PHENOLICS ANALYSES PER YEAR FOR SUBPART E MILLS 90 analyses


[Federal Register: April 5, 2010 (Volume 75, Number 64)]
[Notices]
[Page 17145-17147]
[DOCID:fr05ap10-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0100]

Food Additives; Bisphenol A; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comment.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of five documents related to FDA's continuing assessment
of Bisphenol A (BPA) and soliciting public comments on the four
documents prepared by FDA's Center for Food Safety and Applied
Nutrition (CFSAN). These documents do not represent an agency opinion
or position on BPA, on which an interim update was recently provided.
(See http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm).
Rather, these documents provide perspectives and opinions that are
being considered by FDA as it continues its safety assessment of BPA.
This action will enable FDA to consider comments from the public in its
assessment of BPA for food contact applications.

DATES: Submit written or electronic information and comments by June 4,
2010.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Francis Lin, Center for Food Safety
and Applied Nutrition (HFS-275), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    BPA is a chemical used in certain food contact materials. Uses of
BPA were approved by FDA under its food additive regulations in the
early 1960s. In recent years, questions have been raised about BPA's
safety. On August 14, 2008, FDA delivered its Draft Assessment of BPA
for Use in Food Contact Applications (the Draft Assessment) (Ref. 1) to
a Subcommittee of FDA's Science Board for external review.
    On September 16, 2008, the Subcommittee held a public meeting on
BPA as part of its external review

process, after which the Subcommittee wrote and transmitted its report
to the FDA Science Board. On October 31, 2008, the Science Board
accepted the Subcommittee's report and transmitted it to FDA with
suggestions for revising the Draft Assessment and instructions to
conduct a more in-depth review of certain relatively recent low-dose
studies identified in a draft report, released in April 2008, by the
National Toxicology Program (NTP) Center for the Evaluation of Risks to
Human Reproduction (CERHR) (Ref. 2) and included in the final
assessment completed by the NTP (Ref. 3).
    FDA's Center for Food Safety and Applied Nutrition (CFSAN) has
provided a review, as suggested by the Science Board, of the low-dose
studies mentioned in the NTP report and issued a memorandum describing
that review (Doc. 1).\1\ In this review (Doc. 1), CFSAN also describes
its review of other relevant studies that were either made available
since the publication of the NTP report or suggested by the Science
Board for consideration. Five expert, non-FDA, government scientists
were requested by FDA to conduct a scientific review of CFSAN's
assessment of the low-dose studies. Their reviews are combined and made
available in Doc. 2 and, as such, provide perspectives on Doc. 1 that
may be helpful as additional context, including for those who may want
to comment on the CFSAN documents.
---------------------------------------------------------------------------

    \1\ See table 1 of this document for a description of Document
(Doc.) numbers 1 through 5.
---------------------------------------------------------------------------

    Based on its initial review of these materials, FDA recently
provided an interim update where it expressed ``some concern'' about
the potential effects of BPA on the brain, behavior, and prostate gland
of fetuses, infants, and children, consistent with the final NTP report
(Ref. 3), and indicated steps it is taking and interim recommendations,
to address these concerns (see http://www.fda.gov/NewsEvents/
PublicHealthFocus/ucm064437.htm). FDA also recognized (id.), as did the
NTP review, substantial uncertainties with respect to the overall
interpretation of these studies and their potential implications for
human health effects of BPA exposure. These uncertainties relate to
issues such as the routes of exposure employed, the lack of consistency
among some of the measured endpoints or results between studies, the
relevance of some animal models to human health, differences in the
metabolism (and detoxification) of and responses to BPA both at
different ages and in different species, and limited or absent dose
response information for some studies.
    In a third document (Doc. 3), CFSAN reviews and summarizes a number
of studies of BPA and health that were made available after its
assessment of low-dose studies (Doc. 1). Among the additional studies
summarized in Doc. 3 is an as yet unpublished study focused on the
potential developmental neurotoxicity of dietary BPA in rats (Ref. 4),
which was commissioned by the American Chemistry Council and submitted
to FDA.
    FDA also is making available CFSAN's updated dietary exposure
estimate for the food contact uses of BPA in packaging for infant
formula, baby and adult foods, and polycarbonate nursing bottles (Doc.
4). Finally, FDA is making available CFSAN's review of available
biomonitoring data on BPA (Doc. 5).
    At this time, as FDA continues its safety assessment of BPA, we are
seeking public comment on the four CFSAN documents (Docs. 1, 3, 4, and
5) that are relevant to this safety assessment. While pre-decisional
documents such as these are not required to be made available for
public comment, we believe it is appropriate in this case due to the
complexity of the scientific issues and the degree of public interest
in FDA's scientific assessment of BPA. As we update our assessment,
which may include additional peer review, we will consider any public
comments received, as well as new scientific findings as they become
available. The five documents, which are available in the docket
established for this notice, are listed in table 1 of this document.

                                Table 1.
------------------------------------------------------------------------
Document
   No.       Date                            Title
------------------------------------------------------------------------
1         August 31,  Memorandum from Toxicology Group 1, Division of
           2009        Food Contact Notifications, Office of Food
                       Additive Safety, Center for Food Safety and
                       Applied Nutrition; HFS-275: ``Bisphenol A (CAS
                       RN. 80-05-7): Review of Low-Dose Studies''
------------------------------------------------------------------------
2         November    External Governmental Reviewer Comments on Draft
           2009        Report: ``Bisphenol A (CAS RN. 80-05-7): Review
                       of Low-Dose Studies''
------------------------------------------------------------------------
3         November    Memorandum from Toxicology Group 1, Division of
           24, 2009    Food Contact Notifications, Office of Food
                       Additive Safety, Center for Food Safety and
                       Applied Nutrition; HFS-275: ``Bisphenol A (CAS
                       RN. 80-05-7): studies added to `Review of Low
                       Dose Studies' assessment''
------------------------------------------------------------------------
4         October     Memorandum from: Chemistry Review Group 1,
           22, 2009    Division of Food Contact Notifications and
                       Chemistry Team, HFS-275 and Chemistry Review
                       Team, Division of Biotechnology and GRAS Notice
                       Review, Office of Food Additive Safety, Center
                       for Food Safety and Applied Nutrition; HFS-255:
                       ``Exposure to Bisphenol A (BPA) for infants,
                       toddlers and adults from the consumption of
                       infant formula, toddler food and adult (canned)
                       food''
------------------------------------------------------------------------
5         November    Memorandum from: Regulatory Group 2, Division of
           16, 2009    Food Contact Notifications, Office of Food
                       Additive Safety, Center for Food Safety and
                       Applied Nutrition, HFS-275: ``Summary of
                       Bisphenol A Biomonitoring Studies''
------------------------------------------------------------------------

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received

comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.regulations.gov.

IV. References

    We have placed the following references on display in the Division
of Dockets Management (see ADDRESSES). You may see them between 9 a.m.
and 4 p.m., Monday through Friday. FDA has verified the Web site
addresses, but FDA is not responsible for any subsequent changes to
non-FDA Web sites after this document publishes in the Federal
Register.
    1. Draft Assessment of Bisphenol A for Use in Food Contact
Applications (August 14, 2008). Accessible at: http://www.fda.gov/
food/foodingredientspackaging/ucm166145.htm.
    2. Draft NTP Brief on Bisphenol A, April 14, 2008. Accessible
at: http://cerhr.niehs.nih.gov/chemicals/bisphenol/BPADraftBriefVF_
04_14_08.pdf.
    3. National Toxicology Program, Center for the Evaluation of
Risks to Human Reproduction. NTP-CERHR Monograph on the Potential
Human Reproductive and Developmental Effects of Bisphenol A. NIH
Publication No. 08-5994. September 2008. Accessible at: http://
cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.pdf.
    4. WIL Research Laboratories, LLC. A Dietary Developmental
Neurotoxicity Study of Bisphenol A in Rats (WIL-186056), September
30, 2009.

    Dated: March 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7511 Filed 4-2-10; 8:45 am]
BILLING CODE 4160-01-S