MEMORANDUM

TO:		Public Record for the NPDES Electronic Reporting Rule
		EPA Docket Number EPA-HQ-OECA-2009-0274 (www.regulations.gov)

FROM:		Carey A. Johnston, P.E.
            USEPA/OECA/OC
            ph:<PHONE_NUMBER>
<EMAIL_ADDRESS>
DATE:		14 September 2015

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SUBJECT:	Notes from Technical Meeting with States (19 March 2015) [DCN 0224]
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Overview

      This was the twenty-second meeting between EPA and individual representatives from authorized NPDES programs. These meetings provided greater clarity regarding public comments on the NPDES Electronic Reporting Rule (eRule). Participants are listed below in Tables 1 and 2. EPA is summarizing the notes from these discussions for the docket in order to provide transparency on EPA's outreach during the rulemaking process (see Table 3). EPA also met with other stakeholders to discuss public comments.

Meeting Notes

     EPA (Mr. Carey Johnston) started the meeting by reminding state participants that in addition to raising questions during these meetings, states can email their questions on the proposed rule (including the data elements) to EPA. Questions on all aspects of the proposed rule can be sent to Mr. Johnston. Mr. Johnston also reminded everyone that this outreach does not constitute a decision-making body (see "Quick Reminder" section below).

     Mr. Johnston started the technical discussion by reading the name of each pretreatment data element along with the corresponding data description and regulatory or policy citation. After reading about five to ten elements at a time, Mr. Johnston asked for input from meeting participants. Below are some questions and comments from the meeting participants.

* Several state representatives asked for clarification on the "Listing of Months in SNC" data element. EPA added clarification in the final rule for this data element: "This data element will identify for each Significant Industrial User (SIU) and Non-Significant Categorical Industrial User (NSCIU) the month or months the IU is in SNC within the reporting period. These data must be provided in YYYY-MM format where YYYY is the year and MM is the month." This approach is flexible and will accommodate the different reporting periods used by Approval Authorities.

* A state representative from Missouri ask how the rulemaking addresses how to define significant noncompliance (SNC). Mr. Johnston noted that the rulemaking does not change how EPA defines SNC, rather this rulemaking focuses on transitioning NPDES reporting from a paper to an electronic processing system.

* Several state government representatives asked for clarification on the "Pretreatment Program Approval or Modification Date" data element. EPA provided clarification in the final rule: "The date the pretreatment program was approved or substantially modified. This data element can be system generated by carrying forward the most recent date (approval or modification). The date must be provided in YYYY-MM-DD format where YYYY is the year, MM is the month, and DD is the day." States also requested that EPA include a notation that these data elements do not apply to the development, evaluation, or compliance monitoring activities supporting wastewater surcharge rates. EPA has included this note in the final rule.

* Several state representatives asked for clarification on the `Significant Industrial User Subject to Local Limits" data element. These representatives suggested that EPA limits responses for this data element to "Yes" or "No." EPA has incorporated this suggestion in the final rule.

* Several state representatives asked for clarification on the "Significant Industrial User Wastewater Flow Rate" data element. In the final rule EPA included the following description for this data element: "This data element will identify for each Significant Industrial User (SIU) or Categorical Industrial User (CIU) that is discharging to a POTW (including non-domestic wastewater delivered by truck, rail, and dedicated pipe or other means of transportation) the estimated maximum monthly average wastewater flow rate (in gallons per day)."

* Several state representatives asked for EPA to include the phrase "unique code/description that identifies" for each of the following data elements: Industrial User Causing Problems at POTW, Receiving RCRA Waste, and Receiving Remediation Waste. States requested this change as the use of codes instead of free text fields will help make data entry and sharing easier. EPA included this phrase in the final rule to facilitate easier data entry and sharing.

* Several state representatives asked that EPA delete the "Control Authority Resources" data element from the final rule. EPA has not retained this data element in the final rule.

      Following the meeting, EPA received e-mails from individual state government representatives on the data elements reviewed in this meeting. These e-mails are listed in Attachment 1.

Quick Reminder
   *    The technical workgroup is not a decision-making body. Members of the workgroup provide clarity on their comments and suggest options for consideration by EPA and state senior management.

   *    There are no formal quorum rules for the workgroup. Scheduled teleconferences will proceed with whichever workgroup members call in to participate.

   *    There will be no voting or consensus of the workgroup. Instead, members of the workgroup are providing individual input reflecting their various perspectives.

   *    Summaries of the workgroup's discussions will be prepared for and reviewed by the workgroup, for presentation to EPA senior management and other states and the rulemaking record.

Table 1: State Technical Workgroup Members - 19 March 2015

                                 Main Contact
                             State or Organization
                              Main Contact Email
                         State/Org. Present? (Yes/No)
                                 Sean  Rolland
                                     ACWA
<EMAIL_ADDRESS>                                      Yes
                                 Karen Lechner
                                      AK
<EMAIL_ADDRESS>                                      Yes
                                 Christy Monk
                                      AL
<EMAIL_ADDRESS>                                      Yes
                                 Eric Cleckler

<EMAIL_ADDRESS>
                                  Glenda Dean

<EMAIL_ADDRESS>
                                 Teresa Marks
                                      AR
<EMAIL_ADDRESS>                                      Yes
                                   Pat Goff

<EMAIL_ADDRESS>
                                   Mo Shafii

<EMAIL_ADDRESS>
                                 Karen Bassett

<EMAIL_ADDRESS>
                                 David Ramsey

<EMAIL_ADDRESS>
                                Ellen Carpenter

<EMAIL_ADDRESS>
                                Wendy LeStarge
                                      AZ
<EMAIL_ADDRESS>                                      No
                                 Robin Belley

<EMAIL_ADDRESS>
                                  David Lelsz

<EMAIL_ADDRESS>
                         Darren Polhemus
                                      CA
<EMAIL_ADDRESS>                                      Yes
                       Renee Purdy

<EMAIL_ADDRESS>
                        Deborah Smith

<EMAIL_ADDRESS>
                       Vicky Whitney

<EMAIL_ADDRESS>
                                  Andy Putnam
                                      CO
<EMAIL_ADDRESS><EMAIL_ADDRESS>                                      Yes
                                 Elisa Willard

<EMAIL_ADDRESS>
                                 Bob Zimmerman
                                      DE
<EMAIL_ADDRESS><EMAIL_ADDRESS>                                      Yes
                                   Tom Tyler
                                     ECOS
<EMAIL_ADDRESS>                                      No
                                  Chris Klena
                                      FL
<EMAIL_ADDRESS>                                      Yes
                              Jessica Kleinfelter

<EMAIL_ADDRESS>
                                 Edward Smith

<EMAIL_ADDRESS>

                               Frances Carpenter
                                      GA
<EMAIL_ADDRESS>                                      Yes
                                Scott Miyashiro
                                      HI
<EMAIL_ADDRESS>                                      No
                                 Tom Easterly
                                      IN
<EMAIL_ADDRESS><EMAIL_ADDRESS>                                      Yes
                               Jeremy Chenevert

<EMAIL_ADDRESS>
                                 Mark Stanifer

<EMAIL_ADDRESS>
                               Courtney Cswercko
                                      IA
<EMAIL_ADDRESS>                                      No
                                 Ed Dillingham
                                      KS
<EMAIL_ADDRESS>                                      Yes
                                 Steve Caspers

<EMAIL_ADDRESS>
                             Shelly Shores-Miller

<EMAIL_ADDRESS>
                                Shawn Hokanson
                                      KY
<EMAIL_ADDRESS>                                      Yes
                                  Grace Scott
                                      MI
<EMAIL_ADDRESS>                                      Yes
                                Carla Davidson

<EMAIL_ADDRESS>
                                 Ruth Wallace
                                      MO
<EMAIL_ADDRESS>                                      Yes
                                  Walter Fett

<EMAIL_ADDRESS>
                              Christopher Miller

<EMAIL_ADDRESS>
                                  Tamara Dahl
                                      MN
<EMAIL_ADDRESS>                                      Yes
                                 Paul Scheirer

<EMAIL_ADDRESS>
                                  John Murphy
                                    NEIWPCC
<EMAIL_ADDRESS>                                      No
                        Deborah Gore
                                      NC
<EMAIL_ADDRESS>                                      Yes
                        Bradley Bennett

<EMAIL_ADDRESS>
                                 Jason Lonardo
                                      NJ
<EMAIL_ADDRESS>                                      Yes
                                 Julio Collazo

<EMAIL_ADDRESS>
                                 Robert Wither
                                      NY
<EMAIL_ADDRESS>                                      Yes
                                 Joseph DiMura

<EMAIL_ADDRESS>
                      Alan Tinney
                                  Dave Gaskin
                                      NV
<EMAIL_ADDRESS>                                      Yes

<EMAIL_ADDRESS>
                    Brian Hall
                                      OH
<EMAIL_ADDRESS>                                      Yes
                     Erin Sherer

<EMAIL_ADDRESS>
                             Shellie Chard-McClary
                                      OK
<EMAIL_ADDRESS>                                      Yes
                                  Roy Walker

<EMAIL_ADDRESS>
                                 David Pruitt

<EMAIL_ADDRESS>
                                 Jim Billings
                                      OR
<EMAIL_ADDRESS>                                      Yes
                                 Sean Furjanic
                                      PA
<EMAIL_ADDRESS>                                      No
                                Kent Woodmansey
                                      SD
<EMAIL_ADDRESS>                                      Yes
                                   Tim Flor

<EMAIL_ADDRESS>
                                Albert Spangler

<EMAIL_ADDRESS>
                               Lawrence Bunting
                                      TN
<EMAIL_ADDRESS>
                                      Yes
                                 Yatasha Moore

<EMAIL_ADDRESS>

                                  Kim Wilson
                                      TX
<EMAIL_ADDRESS>                                      Yes
                               Rebecca Villalba

<EMAIL_ADDRESS>
                                 Lynley Doyen

<EMAIL_ADDRESS>
                               Kimberly Shepard

<EMAIL_ADDRESS>
                                 Jeff Studenka
                                      UT
<EMAIL_ADDRESS>                                      No
                                 Jerome Brooks
                                      VA
<EMAIL_ADDRESS>                                      Yes
                                Deborah Debiasi

<EMAIL_ADDRESS>
                                  Phani Eturu

<EMAIL_ADDRESS>
                                Stephen Bernath
                                      WA
<EMAIL_ADDRESS>                                      Yes
                                  Dave Knight

<EMAIL_ADDRESS>
                                  Nancy Kmet

<EMAIL_ADDRESS>
Participants in this meeting also included state representatives from Idaho, Louisiana, Mississippi, Montana, New Hampshire, New Mexico, North Dakota, South Carolina, and Wisconsin.

Table 2: EPA Technical Workgroup Members

                                     Name
                                  EPA Office
                                     Email
                               Present? (Yes/No)
                                John Dombrowski
                                 OECA/OC/ETDD
<EMAIL_ADDRESS>                                      No
                                  Andy Hudock
                                 OECA/OC/ETDD
<EMAIL_ADDRESS>                                      Yes
                                Rochele Kadish
                                 OECA/OC/ETDD
<EMAIL_ADDRESS>                                      No
                                Carey Johnston
                                 OECA/OC/ETDD
<EMAIL_ADDRESS>                                      Yes
                                 Jackie Clark
                                  OW/OWM/WPD
<EMAIL_ADDRESS>                                      Yes
                                  Jan Pickrel
                                  OW/OWM/WPD
<EMAIL_ADDRESS>                                      Yes
                                Ginny Phillips
                                 OECA/OCE/WED
<EMAIL_ADDRESS>                                      Yes
                                 Aditi Prabhu
                                    OGC/WLO
<EMAIL_ADDRESS>                                      No
                                 David Apanian
                                   Region 4
<EMAIL_ADDRESS>                                      Yes
                                  Sandra Chew
                                   Region 9
<EMAIL_ADDRESS>                                      No
                                  Glynis Hill
                                 OP/ORPM/PRAD
<EMAIL_ADDRESS>                                      No

Table 3: State Technical Workgroup Discussions to Discuss Public Comments

                                      DCN
                                     Date
Topic
Data Source
                                   DCN 0219
                                  02/05/2015
Basic Facility and Permit Data
Ind. Permit Applications/NOIs
                                   DCN 0220
                                  02/12/2015
Basic Violation and Enforcement Action Data
States & Ind. Permit Applications/NOIs
                                   DCN 0221
                                  02/26/2015
Municipal Separate Storm Sewer System (MS4) Information
Ind. Permit Applications/NOIs & MS4 Program Report
                                   DCN 0222
                                  03/05/2015
Construction and Industrial Stormwater Information
Ind. Permit Applications/NOIs
                                   DCN 0223
                                  03/12/2015
CSO & Collection System Information & Sewer Overflow Data
Ind. Permit Applications/NOIs & Sewer Overflow Event Reports
                                   DCN 0224
                                  03/19/2015
Pretreatment Data
Ind. Permit Applications/NOIs & Annual POTW Pretreatment Program Reports, CIU/SIU Reports When EPA or State is Control Authority
                                   DCN 0225
                                  03/26/2015
Cooling Water and Thermal Variance Data
Ind. Permit Applications/NOIs
                                   DCN 0226
                                  04/02/2015
Biosolids Data
States & Ind. Permit Applications/NOIs & Annual Biosolids Reports
                                   DCN 0227
                                  04/09/2015
CAFO Data
Ind. Permit Applications/NOIs & Annual Biosolids Reports
                                   DCN 0228
                                  05/13/2015
Review of Appendix A
All NPDES program data
                                   DCN 0229
                                  05/27/2015
Review of State Representative Questions to EPA
All NPDES program data

   Attachment 1 - Emails from Representatives from Authorized NPDES Programs
E-mail from David Ramsey<EMAIL_ADDRESS>Thu 3/12/2015 3:20 PM
ADEQ does not have a permit for CIUs where the State is the control authority. When we entered the ARPs into PCS we did not have to enter the permit issue, effective, and expiration dates, so when they were migrated to ICIS and the data elements were required, they were marked as "Pending".  We could use the POTW dates, but since the State is the control authority, neither State nor the permittee issues permits or permit coverage to these facilities (as far as I know).
Also, if we used the POTW dates, we would have to renew all of the CIUs and update their information in ICIS-NPDES every time we renew the POTW permit (unless this could be done automatically.  Another problem is that the ICIS staff does not receive updates when CIUs are added, terminated, or updated (transfer of ownership, legal name changes, changes of authorization, etc.).
If all of this information is automatically populated through the permit application in electronic reporting system, I guess my opinion really won't make any difference.
EPA RESPONSE: EPA is interpreting its existing regulation at 40 CFR 403.12(i) to include Industrial User (IU) effective and expiration dates. EPA notes that many Regions and States have already been requiring that information as either a way to key the IU facilities to previous lists [see 403.12(i)(1) as well as under 403.12(i)(5)].
E-mail from Tina McFarling<EMAIL_ADDRESS>Mon 3/23/2015 9:51 AM
I have a few questions and concerns that came up during the conference call last Thursday. The first concern is on the permit application section for NPDES permits. South Dakota is the control authority for the majority of POTWs in the state. How will our POTWs know what to enter under the control authority's NPDES number? Will that information be readily available for our POTWs. I'm just worried that their applications will not be accepted without this information and this will cause further delays in the permitting process.
EPA RESPONSE: The NPDES Electronic Reporting rule is not requiring NPDES application forms to be submitted electronically.  The NPDES Electronic Reporting rule is focused on required reports like Discharge Monitoring Reports (DMRs), Notices of Intent (NOIs), and Program Reports (examples:  Approved POTW Pretreatment Program annual report and annual sludge reports).  Consequently, South Dakota's permit drafting shouldn't be affected. As a matter of good oversight and practice, the NPDES permit writing staff and pretreatment staff should be working together to review the applications [which includes that the POTW is required to identify SIUs and other discharges per 40 CFR 122.21(j)(6) & (7)] and to ensure that the appropriate permit conditions are included in all POTW permits.
The second question and concern is about the two data elements that I brought up during the conference call. On the annual reports section there is a proposed data element for the IU's control mechanism's effective and expiration dates. As I brought up in the conference call, 40 CFR 403.12(i) does not specifically require this information and we are concerned about adding these specific data elements because the proposed rule is not supposed to be changing current requirements. Also, I have a question about 40 CFR 403.12(i)(5). Will there be a way that the approval authority require additional information and for the approved POTWs to report that information electronically?
EPA RESPONSE: EPA is interpreting its exiting regulation at 40 CFR 403.12(i) to include Industrial User (IU) effective and expiration dates. EPA notes that many Regions and States have already been requiring that information as either a way to key the IU facilities to previous lists [see 403.12(i)(1) as well as under 403.12(i)(5)].  It is particularly relevant when the approved POTW programs have reviewed or changed local limits per 40 CFR 122.44(j)(2)(ii) and the IU permit effective/modification/expiration date information helps demonstrate that the POTW is implementing new local limits. Regarding the last question, "Will there be a way that the approval authority require additional information and for the approved POTWs to report that information electronically," the final rule only requires electronic reporting of Appendix A data. All other data, non-Appendix A data, can be submitted on paper to the authorized NPDES program or electronically submitted as attachments to the NPDES forms. EPA's electronic reporting tools (NetDMR, NeT) are an example of such an arrangement, as they currently allow for electronic attachments (e.g., PDF files, CSV files). The final rule provides flexibility to states to customize their electronic reporting tools to collect additional information beyond the Appendix A requirements.
My final comment is about the annual report requirement for listing the months that the SIU is in SNC. I was confused, as SNC is calculated on a quarterly basis. I talked with Al Garcia from Region 8 for more clarification and I understand that this is more for tracking how long before the SIU is in compliance. I think that this data element may confuse some users (as it confused me) and additional explanation that this is for determining how long an SIU is out of compliance and not the actual SNC determination calculation may be needed.
EPA RESPONSE: EPA's existing report requirements [40 CFR 403.12(i)(3)] require reporting on a "summary of the status of Industrial User compliance over the reporting period." EPA is using the "Listing of Months in SNC" data element to track the months each SIU/CIU is in SNC. It is important to note that this rulemaking does not redefine SNC for the pretreatment program.
E-mail from Grace Scott<EMAIL_ADDRESS>Tue 3/24/2015 6:42 PM
During the call we talked about the SIU data and how it will need to be added.  Currently, the complete SIU lists (with detailed information) come in with the permit application.  Annual reports only describe additions and subtractions.  Will it take a full five year permit cycle to fully populate the database or will POTWs and/or states be expected to add all the background SIU information the first year?  Certainty, there will a need to have at least some SIU info entered initially, but will the bulk of it be required up front or with the permit application?
EPA RESPONSE: EPA's existing NPDES permit applications require a full listing of SIU/CIUs [see 40 CFR 122.21(j)(6)]. EPA is requiring authorized NPDES programs to share these data with EPA. EPA is implementing this final rule over five years, which should provide enough time for all authorized NPDES programs to share information on SIU/CIUs in advance of the deadline for the Pretreatment Program Report [403.12(i)], which is five years after the effective date of the final rule.

E-mail from Valentin Kouame<EMAIL_ADDRESS>Mon 3/30/2015 11:51 AM
The New Jersey Department of Environmental Protection (NJDEP) is offering the following comments on the data elements for pretreatment electronic reporting following the March 10, 2015 and March 19, 2015 teleconference calls between EPA and the States.
Local Limits Adoption Date: The most recent date on which the Control Authority has adopted new local limits within the reporting period.
Comment: This data entry is in conformity with the ICIS data entry. In New Jersey, any local limits developed by a delegated POTW (POTW with an approved pretreatment program) and approved by the NJDEP must be adopted by the POTW's Board of Commissioners in accordance with the local law in order to be incorporated in the POTW's local Sewer Use Ordinance (SUO) or Rules and Regulations for legal implementation and enforcement. Without that adoption, the local limits are not enforceable.
EPA RESPONSE: EPA has included the "Local Limits Adoption Date" and "Local Limits Evaluation Date" data elements in the final rule.
SNC with Pretreatment Standards (Program Report): This data element will identify for each Significant Industrial User (SIU) and Non-Significant Categorical Industrial User (NSCIU) that is discharging (including truck transportation) to this POTW whether the IU was in Significant Non-Compliance (SNC) with pretreatment requirements in the reporting period.
SNC with Pretreatment Standards Pollutants (Program Report): This data element will identify for each Significant Industrial User (SIU) and Non-Significant Categorical Industrial User (NSCIU) that is discharging (including truck transportation) the pollutants that related to the IU's Significant Non-Compliance (SNC) with pretreatment requirements in the reporting period.
SNC with Other Control Mechanism Requirements (Program Report): This data element will identify for each Significant Industrial User (SIU) and Non-Significant Categorical Industrial User (NSCIU) that is discharging (including truck transportation) to this POTW whether the IU was in Significant Non-Compliance (SNC) with any other control mechanism requirements in the reporting period.
Comment: 40 CFR 403.8(f)(2)(viii)(A) through (H) specify eight (8) specific SNC criteria. The descriptions of data elements for SNC are grouped into four (4) groups which are not consistent with the existing ICIS Pretreatment data entry for SNC criteria grouping, and the existing SNC criteria grouping noted on page PCA-14 , Section I.F.3.a of the EPA's Control Authority Pretreatment Audit Checklist. In order to avoid any confusion and ensure consistency in the pretreatment data reporting, the NJDEP recommends two (2) options for the data elements for SNC criteria grouping:
Option 1 (similar to ICIS Data Entry):
   * SNC with pretreatment standards pursuant to 40 CFR 403.8(f)(2)(viii)(A), (B), (C), (D), and (H),
   * SNC with reporting requirements pursuant to 40 CFR 403.8(f)(2)(viii)(F) and (G)
   * SNC with pretreatment compliance schedule(s) pursuant to 40 CFR 403.8(f)(2)(E)

Option 2 (similar to Pretreatment Audit Checklist)
   * SNC with applicable pretreatment standards and other reporting pursuant to 40 CFR 403.8(f)(2)(viii)(A), (B), (C), (D), (G), and (H),
   * SNC with self-monitoring requirements pursuant to 40 CFR 403.8(f)(2)(viii)(F)
   * SNC with pretreatment compliance schedule(s) pursuant to 40 CFR 403.8(f)(2)(E)
In addition, the NJDEP recommends that a reference citation be included with each SNC criteria grouping.
EPA RESPONSE: EPA will work with states to identify the possible reference values for these four data elements: SNC with Pretreatment Standards or Limits (Program Report), SNC with Pretreatment Standards or Limits Pollutants (Program Report), SNC with Reporting Requirements (Program Report), and SNC with Other Control Mechanism Requirements (Program Report). EPA will also develop training and guidance on how to properly report these data elements.
Industrial User Biosolids Contamination Indicator (Program Report): This data element will identify for each Significant Industrial User (SIU), Dental Industrial User (DIU), and Non-Significant Categorical Industrial User (NSCIU) whether the Industrial User caused or contributed to any problems with the receiving POTW's biosolids in the previous reporting period. EPA regulations require the Control Authority to develop and enforce local limits when the discharge from an IU causes or contributes to any problems (e.g., pass-through or interference) at the receiving POTW.
POTW Biosolids Contamination Indicator (Program Report): A unique code/description that identifies whether there have been any problems (e.g., pass-through or interference) with the receiving POTW's biosolids within the reporting period.
Comment: These two data elements noted above include the pass-through prohibition. The definition of pass-through under 40 CFR 403.3(p) does not involve an inhibition or disruption of the POTW's sludge processes, or the prevention of the POTW's chosen sludge management, rather a discharge exiting the POTW's treatment plant without treatment and causing a violation of the POTW's NPDES permit. Therefore, these two data elements should be based on the interference prohibition in accordance with the General Pretreatment Regulations, 40 CFR 403.3(k), which includes the prohibition of inhibition or disruption of the POTW's sludge processes, use or management. Thus, references to pass-through should be removed.
In addition, as mentioned by some callers, the definitions of the terms pass-through and interference should be included or referenced.
EPA RESPONSE: EPA revised these two data elements to read as follows.
   * POTW Biosolids or Sewage Sludge Contamination Indicator (Program Report): The one or more unique codes/descriptions that identify any problems (e.g., interference with the use or disposal of biosolids or sewage sludge, violation of NPDES permit requirements or EPA's regulations at 40 CFR 503) with the receiving POTW's biosolids or sewage sludge within the reporting period. See 40 CFR 403.3(k). EPA regulations require any Control Authority that must develop a Pretreatment Program also to develop and enforce local limits to ensure that the discharge from an IU does not cause or contribute a disruption of biosolids' use or disposal at the receiving POTW.
   * Industrial User Biosolids or Sewage Sludge Contamination Indicator (Program Report): The one or more unique codes/descriptions that identify for each Significant Industrial User (SIU) and Non-Significant Categorical Industrial User (NSCIU) whether the Industrial User caused or contributed to any problems (e.g., interference with the use or disposal of biosolids or sewage sludge, violation of NPDES permit requirements or EPA's regulations at 40 CFR 503) with the receiving POTW's biosolids or sewage sludge in the previous reporting period. See 40 CFR 403.3(k). EPA regulations require the Control Authority to develop and enforce local limits when the discharge from an IU causes or contributes to any problems e.g.at the receiving POTW.


33125 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices Region VII, 901 N. 5th Street, Kansas City, Kansas 66101.

SUPPLEMENTARY INFORMATION: This proposed settlement is intended to resolve the liability of Saveway Petroleum at the Great Lakes Container Corporation Superfund Site in St. Louis, Missouri. Great Lakes Container Corporation is a former drum reclamation company who operated at the Site from 1976 to 1985. The same business was operated as Northwestern Cooperage from the 1950' s to 1976 and then operated as Great Lakes Container Corporation. EPA conducted a time critical removal completed in 1998 that consisted primarily of soil and drum removal. The EPA incurred costs of approximately $ 9,127,244.30. The hazardous substances at this Site consisted primarily of lead and polychlorinated biphenyls. Liability is based on the theory that de minimis parties arranged for disposal of hazardous substances at the Site by shipping drums for reclamation coated with paint containing lead. The de minimis parties either admitted that they sent drums for reclamation to the Site or EPA had separate evidence to prove that de minimis parties sent drums for reclamation to the Site. This settlement is being offered to Saveway because it is liable for no more than one quarter a percent (. 25%) of EPA's past costs at the Site. The majority of de minimis parties are each required to pay $ 4,839.44 or $ 5,133.72 depending on whether the party was required to pay prejudgment interest. Other settlements made for six de minimis parties varied from $ 3,794.19 to $ 22,856.56 because more volumespecific information was available for them allowing EPA to refine the calculation. The amount and toxicity of hazardous substances contributed by Saveway was minimal as compared to other parties' shares of hazardous substances. The EPA determined this amount to be Saveway's fair share of liability based on the amount of hazardous substances generated and disposed of at the Site and the volume of waste contributed. However, because Saveway has demonstrated an inability to pay, it will not be required to pay any of EPA's past costs at the Site. As a result, Saveway has agreed to provide access to EPA and maintain records for five ( 5) years. The settlement also includes contribution protection from lawsuits by other potentially responsible parties as provided for under section 122( g)( 5) of CERCLA, 42 U. S. C. 9622( g)( 5). The de minimis settlement provides that EPA covenants not to sue Saveway for response costs at the Site or for injunctive relief pursuant to sections 106 and 107 of CERCLA and section 7003 of the Resource Conservation and Recovery Act of 1976, as amended ( RCRA), 42 U. S. C. 6973. The settlement contains a reopener clause which nullifies the covenant not to sue if any information becomes known to EPA that indicates that Saveway no longer meets the criteria for a de minimis settlement set forth in section 122( g)( 1)( A) of CERCLA, 42 U. S. C. 9622( g)( 1)( A). The United States maintains the ability to bring an action in the event that the financial information provided by Saveway was false. The covenant not to sue does not apply to the following matters: ( a) Claims based on the future arrangement for disposal or treatment of any hazardous substance, pollutant, or contaminant at the Site after the effective date of the de minimis settlement; ( b) Criminal liability; or ( c) Liability for damages or injury to, destruction of, or loss of the natural resources and for the costs of any natural resource damage assessments. The de minimis settlement will become effective upon the date which the EPA issues a written notice to Saveway that the statutory public comment period has closed and that comments received, if any, do not require modification, of or EPA withdrawal from the settlement.

Dated: May 22, 2003. James B. Gulliford, Regional Administrator, Region VII. [ FR Doc. 03   13565 Filed 6   2   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPPT   2003   0010; FRL   7300   6]

1,2 Ethylene Dichloride; Final Enforceable Consent Agreement and Testing Consent Order AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: Under section 4 of the Toxic Substances Control Act ( TSCA), EPA has issued a testing consent order ( Order) that incorporates an enforceable consent agreement ( ECA) with the Dow Chemical Company, Vulcan Materials Company, Occidental Chemical Corporation, Oxy Vinyls, LP, Georgia Gulf Corporation, Westlake Chemical Corporation, PPG Industries, Inc., and Formosa Plastics Corporation, U. S. A. The Companies are members of the Hazardous Air Pollutant ( HAP) Task Force, which represents the manufacturers of 1,2 ethylene dichloride ( EDC). The Companies have agreed to: Conduct toxicity testing, develop pharmacokinetics and mechanistic test data, and develop a computational dosimetry model for quantitative route to route extrapolations of dose response for EDC for acute, subchronic, developmental, reproductive and neurotoxicity effects that were identified in a proposed test rule for hazardous air pollutants. This notice announces the ECA and Order for EDC and summarizes the terms of the ECA.

DATES: The effective date of the ECA and Order is May 13, 2003.

FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division ( 7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 554   1404; e mail address: TSCA Hotline@ epa. gov. For technical information contact: Richard Leukroth or John Schaeffer, Chemical Control Division ( 7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 564   8157; fax number: ( 202) 564   4765; e mail address: ccd. citb@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

This announcement is directed to the public in general. However, as described in Unit IV., this ECA and Order may affect others in that EPA has initiated rulemaking under TSCA section 12( b) ( 62 FR 67038, December 23, 1997) ( FRL   5762   8). When finalized, that rulemaking will require all persons who export or intend to export EDC to comply with the export notification regulations at 40 CFR part 707, subpart D. Although others may be affected by subsequent actions related to this announcement, this ECA and Order only applies to those Companies that are specifically named in this ECA and Order. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

VerDate Jan< 31> 2003 21: 13 Jun 02, 2003 Jkt 200001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 03JNN1. SGM 03JNN1 OPPT 2003 0010 0001 RECEIVED OPPT NCIC 2003 JUN 3 7: 09AM 33126 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPPT   2003   0010. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102   Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is ( 202) 566   1744 and the telephone number for the OPPT Docket, which is located in the EPA Docket Center, is ( 202) 566   0280. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background A. What is EDC?

EDC is used as a chemical intermediate principally in the production of vinyl chloride, but also vinylidene chloride, 1,1,1 trichloroethane, trichloroethylene, tetrachloroethylene, aziridines, and ethylene diamines. It is also used as a solvent. An estimated 77,111 workders are exposed to EDC ( Ref. 1). The Chemical Abstract Service Registry Number ( CAS No.) for EDC is 107   06   2. B. Why Does EPA Need Health Effects Data on EDC?

EPA proposed health effects testing under TSCA section 4( a) for a number of hazardous air pollutants (`` HAPs'' or `` HAP chemicals''), including EDC ( 61 FR 33178, June 26, 1996) ( FRL   4869   1), as amended at 62 FR 67466, December 24, 1997 ( FRL   5742   2) and 63 FR 19694, April 21, 1998 ( FRL   5780   6). In the original HAPs proposal, the Agency made preliminary findings for EDC ( 61 FR 33178, 33190, 33191; and Ref. 1) that: 1. EDC may present an unreasonable risk of injury to health. 2. EDC is or will be produced in substantial quantities, and there is or may be substantial human exposures to the chemical. 3. There are insufficient data to determine or predict the effects of activities on human health involving EDC. 4. Testing is necessary to develop health effects data for EDC. The HAPs rule, as amended, proposed testing of EDC for acute toxicity, subchronic toxicity, developmental toxicity, reproductive effects toxicity, and neurotoxicity ( 61 FR 33178, 33198, June 26, 1996; 62 FR 67466, 67483, December 24, 1997).

III. ECA Development and Conclusion A. How is EPA Going to Obtain Health Effects Testing on EDC?

In the proposed HAPs test rule, as amended, EPA invited the submission of proposals regarding the performance of pharmacokinetics studies that would permit extrapolation from oral data to predict risk from inhalation exposure. Such proposals could provide the scientific basis for alternative testing to the testing proposed and form the basis for developing needed HAPs data via ECAs ( 61 FR 33178, 33189, June 26, 1996; 62 FR 67466, 67474, December 24, 1997). EPA uses ECAs to accomplish testing where a consensus exists among EPA, affected manufacturers and/ or processors, and interested members of the public concerning the need for and scope of testing ( 40 CFR 790.1( c)). The procedures for ECA development are described at 40 CFR 790.22( b). In response to EPA's request for proposals for ECAs, the HAP Task Force submitted a proposal for alternative testing that included physiologicallybased pharmacokinetics ( PBPK) studies and computational modeling to inform route to route extrapolations of doseresponse for EDC on November 22, 1996 ( Ref. 2). EPA responded to this proposal on June 26, 1997 ( Ref. 3), indicating that the HAP Task Force alternative approach offered sufficient merit to proceed with discussions for developing an ECA for EDC. Consequently, EPA issued a document which was published in the Federal Register of December 19, 1997 ( 62 FR 66626) ( FRL   5763   1), soliciting interested parties to monitor or participate in these discussions. EPA held a public meeting to develop an ECA for EDC on January 12, 1998. Representatives of the Companies and other interested parties attended this meeting. The participants reached consensus on the general scope of the testing to be required under the ECA. Following the public meeting, the HAP Task Force submitted ( March 19, 1999) a revised proposal for a testing program ( Ref. 4). On February 13, 2001, EPA responded to the HAP Task Force with comments on the revised proposal and by initiating a draft ECA for consideration by the HAP Task Force ( Ref. 5). A final version of the ECA was later circulated to the HAP Task Force for signature, and returned to EPA for signature. On February 3, 2003, EPA received the ECA signed by the Companies. On May 13, 2003, EPA signed the ECA and accompanying Order ( Ref. 6).

B. What Testing Does the ECA for EDC Require? The EDC ECA alternative testing program has four segments as follows: Tier I HAPs Testing, Tier I Program Review Testing, EPA Program Review, and Tier II Testing. This is described in Table 1 in this unit and includes the following testing, reporting, and review activities: 1. Tier I HAPs Testing. This testing consists of endpoint testing, conducted by inhalation exposure, that EPA deemed necessary to meet certain data needs identified in the proposed HAPs test rule, as amended, and includes acute toxicity with bronchoalveolar lavage ( BAL) and histopathology, and acute neurotoxicity testing. These tests will be conducted under a combined protocol as described in Appendix D. 1 of the ECA. 2. Tier I Program Review Testing. Under this segment of the EDC ECA alternative testing program, the Companies will conduct studies to extend the computational dosimetry model of D'Souza et al. ( 1987; 1988; Refs. 7 and 8) in order to apply the model to the specific health effects endpoints for EDC listed in the ECA, validate the model, and verify the model's ability to perform quantitative route to route extrapolations of doseresponse In addition, the Companies will sponsor development of VerDate Jan< 31> 2003 21: 13 Jun 02, 2003 Jkt 200001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 03JNN1. SGM 03JNN1 33127 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices pharmacokinetics and mechanistic ( PK/ MECH) data to support the application of the model for the endpoints listed under Tier II of the EDC ECA. Specifically, the PK/ MECH testing will develop data to inform: i. Oral to inhalation extrapolation of subchronic toxicity data reported by Daniel, et al. ( 1994; Ref. 9) relevant to corn oil gavage. ii. Oral to inhalation extrapolation of subchronic neurotoxicity data relevant to drinking water exposure of a study to be conducted under Tier II Testing. iii. Oral to inhalation extrapolation of reproductive effects testing conducted under Tier II Testing and each dosing paradigm of studies reported by Alumot et al. ( 1976; Ref. 10), Rao, et al. ( 1980; Ref. 11) and Lane et al. ( 1982; Ref. 12). In addition, the Companies will provide model simulations with point and uncertainty estimates of internal dose metrics ( parent chemical peak and area under the curve ( AUC) concentrations in blood and brain, and 24 hour total glutathione dependent metabolism) in rats and humans to inform quantitative route to route extrapolations of dose response. These simulations will be used to evaluate the acceptability of: Subchronic neurotoxicity testing of oral exposure via drinking water in rats, extant oral subchronic toxicity data of Daniel et al. ( 1994; Ref. 9) in rats via corn oil gavage, and reproductive toxicity testing of oral exposure via drinking water in rats. 3. EPA Program Review. Model development and data from Tier I Program Review Testing are subject to an EPA Program Review. It is essential to the success of the EDC ECA alternative testing program for EPA to ensure that the model and the PK/ MECH data used to support the routeto route extrapolations of dose response are of the highest quality. The purpose of the EPA Program Review will be to determine: i. Whether it is feasible and appropriate to apply Tier I Program Review Testing data and data from other studies acceptable to EPA to support computational route to route extrapolations of dose response for endpoints listed in the Tier II Testing segment of the ECA. ii. Whether the data from the Tier I Program Review Testing segment provide a sufficient basis for conducting the endpoint testing and/ or the computational route to route extrapolations for the dose responses specified in the Tier II Testing segment. iii. The nature and scope of any additional work that may be required before Tier II Testing and application of the EDC model for route to route extrapolation of dose response reporting ( e. g., development of additional PK/ MECH data, modification to the EDC model). 4. Tier II Testing and/ or Extrapolation Reporting. This segment of the EDC ECA alternative testing program consists of endpoint testing by drinking water exposure for subchronic neurotoxicity and reproductive toxicity. The reproductive effects toxicity testing is intended to confirm studies reported by Alumot et al. ( 1976; Ref. 10), Rao et al. ( 1980; Ref. 11), and Lane et al. ( 1982; Ref. 12), and provide data needed on fertility index, gestation index, gross necropsy, organ weight, histopathology, estrous cycle, sperm evaluation, vaginal opening, and preputial separation as described in the ECA. This segment will also include application of the EDC model for quantitative route to route extrapolation reporting ( oral to inhalation) for Tier II endpoint testing ( subchronic neurotoxicity and reproductive toxicity) and similar computational extrapolation reporting for extant subchronic toxicity reported by Daniel et al. ( 1994; Ref. 9). Testing conducted under this ECA will allow EPA to characterize certain potential health hazards resulting from inhalation exposure to EDC. The following Table 1 sets forth the required testing, test standard, and reporting requirements under the ECA for EDC.

TABLE 1.   REQUIRED TESTING, TEST STANDARD, AND REPORTING REQUIREMENTS FOR EDC Testing Segment Required testing Test standard Deadline for final report1 ( Months)

Tier I HAPs Testing. Acute toxicity, with BAL and histopathology ( inhalation). 40 CFR 799.9135 ( as annotated in ECA Appendix D. 1). 18 Acute neurotoxicity ( inhalation). 40 CFR 799.9620 ( as annotated in ECA Appendix D. 1). 18 Tier I Program Review Testing. PK/ MECH data to support model validation and verification of oral to inhalation extrapolation of dose response for the following data needs in the F344 rat: ECA Appendix C ( 1   4). 21 a. Subchronic toxicity. b. Subchronic neurotoxicity. c. Reproductive toxicity. PBPK model simulations. ECA Appendix C ( 1   5). 21 Tier II Testing and/ or Extrapolation Reporting. Subchronic toxicity route to route extrapolation of dose response ( oral Tier II Testing to inhalation) of a study reported by Daniel et al. ( 1994). ECA Appendix C. 2 and C. 6. 36 Subchronic neurotoxicity ( oral). 40 CFR 799.9620 ( as annotated in ECA Appendix D. 2). 42 Subchronic neurotoxicity route to route extrapolation of dose response ( oral Tier II Testing to inhalation). ECA Appendix C. 3 and C. 6. 52 Reproductive toxicity ( oral). 40 CFR 799.9380 ( as annotated in ECA Appendix D. 3). 42 VerDate Jan< 31> 2003 21: 13 Jun 02, 2003 Jkt 200001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 03JNN1. SGM 03JNN1 33128 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices TABLE 1.   REQUIRED TESTING, TEST STANDARD, AND REPORTING REQUIREMENTS FOR EDC   Continued Testing Segment Required testing Test standard Deadline for final report1 ( Months)

Reproductive toxicity route to route extrapolation of dose response ( oral data to inhalation, including Tier II Testing and extant studies reported by Alumot et al. ( 1976), Rao et al. ( 1980), and Lane et al. ( 1982)). ECA Appendix C. 4 and C. 6. 52 1 Number of months after the effective date of the Order that incorporates this ECA when the final report is due. In addition, every 6 months from the effective date of the Order until the end of the ECA testing program, interim reports describing the status of all testing to be performed under this ECA must be submitted by the Companies to EPA.

C. What are the Uses for the Test Data for EDC?

EPA would use the data obtained from testing to implement several provisions of section 112 of the Clean Air Act ( CAA), including the determination of residual risk, the estimation of the risks associated with accidental releases of chemicals, and other HAP risk assessments. EPA will also use the data from this ECA to fulfill part of the Tier I Testing portion of the Voluntary Children's Chemical Evaluation Program ( VCCEP). ( For more information about VCCEP, see: http:// www. epa. gov/ chemrtk/ vceep/.) In addition, the data will be used by other Federal agencies ( e. g., the Agency for Toxic Substances and Disease Registry ( ATSDR), the National Institute for Occupational Safety and Health ( NIOSH), the Occupational Safety and Health Administration ( OSHA), and the Consumer Product Safety Commission ( CPSC)) in assessing chemical risks and in taking appropriate actions within their programs ( see the proposed HAPs test rule at 61 FR 33178, 33179, June 26, 1996).

D. Does the ECA for EDC Meet all the Testing Requirements for EDC that were Contained in the Proposed Test Rule?

In the proposed HAPs test rule, as amended, EPA proposed testing of EDC for acute, subchronic, developmental, and reproductive effects and neurotoxocity by the inhalation route of exposure. The ECA alternative testing program for EDC requires inhalation testing for acute toxicity and acute neurotoxicity, and oral drinking water testing for subchronic neurotoxicity and reproductive effects toxicity. The ECA requires the development of PK/ MECH data to support computational PBPK modeling to inform quantitative routeto route extrapolations of dose response ( oral to inhalation) for the endpoints of subchronic toxicity, subchronic neurotoxicity, and reproductive effects toxicity as described in the ECA. During discussions to develop this ECA, EPA concluded that the developmental toxicity studies reported by Rao et al. ( 1980; Ref. 11), in rabbits, and Payan et al. ( 1995; Ref. 13), in rats, adequately fulfill the HAPs rulemaking testing requirement for developmental toxicity testing for EDC and, therefore, the ECA does not require, and the final HAPs test rule will not require this testing. In addition, the ECA does not require, and the final HAPs test rule will not require, macrophage function testing ( a component of EPA's acute toxicity test gudeline 40 CFR 799.9135) because EPA considers existing data by Sherwood et al. ( 1987; Ref. 14) adequate to fulfill this aspect of the acute testing need. Furthermore, the Tier I HAPs Testing endpoints ( acute toxicity and acute neurotoxicity) will not be included in the final HAPs test rule because the route of testing to be conducted under this ECA is identical to that specified in the HAPs rulemaking. Finally, depending on the outcome of EPA's Program Review, the Agency anticipates that the balance of the testing for EDC that was contained in the proposed HAPs test rule, as amended, will also not be included in the final HAPs test rule because the Companies will conduct equivalent testing as Tier II Testing and Extrapolation Reporting under this ECA alternative testing program for EDC. Therefore, EPA anticipates the fulfilling of all of the health effects testing requirements, identified in the HAPs proposed rule, as amended, by implementing the ECA and Order. The issuance of the ECA and Order constitutes final EPA action for purposes of 5 U. S. C. 704.

E. What if EPA Should Require Additional Health Effects Testing on EDC? If EPA decides in the future that it requires additional health effects data on EDC, the Agency will initiate a separate action.

IV. Other Impacts of the ECA for EDC The issuance of the ECA and Order under TSCA section 4 subjects the Companies that signed the ECA to export notification requirements under TSCA section 12( b)( 1), as set forth at 40 CFR part 707, subpart D, if they export or intend to export EDC. In the 12( b) proposal published in the Federal Register of December 23, 1997 ( 62 FR 67038) ( FRL   5762   8), EPA proposed to amend 40 CFR 799.5000 by adding EDC to the list of chemicals subject to testing consent orders. The listing of a chemical substance at 40 CFR 799.5000 serves as notification to all persons who export or intend to export the chemical substance that: 1. The chemical substance is the subject of an ECA and Order. 2. EPA's export notification regulations at 40 CFR part 707, subpart D, apply to those exporters who have signed the ECA, as well as those exporters who have not signed the ECA ( 40 CFR 799.19). When a final rule based on the proposed rule is published in the Federal Register, all persons who export or who intend to export EDC will be subject to export notification requirements.

V. Paperwork Reduction Act The ECA and Order announced in this notice do not contain any information collection requirements that require additional approval by the Office of Management and Budget ( OMB) under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq. The information collection requirements related to test rules and ECAs issued under TSCA section 4 have already been approved by OMB under OMB control number 2070   0033 ( EPA ICR No. 1139). The one time public burden for this collection of information is estimated to be approximately 3,364 hours total ( Ref. 15). Under the PRA, `` 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. For this collection it includes the time needed to review instructions; complete and review the collection of information; and transmit or otherwise disclose the information. An agency VerDate Jan< 31> 2003 21: 13 Jun 02, 2003 Jkt 200001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 03JNN1. SGM 03JNN1 33129 Federal Register / Vol. 68, No. 106 / Tuesday, June 3, 2003 / Notices 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 number for EPA's regulations, after initial display in the final rule, are listed in 40 CFR part 9.

VI. References 1. U. S. EPA, OPPT. I. Ethylene Dichloride ( 107   06   2). Pp 24   27 In: `` TSCA Section 4 Findings for 21 Hazardous Air Pollutants: A Supporting Document for Proposed Hazardous Air Pollutants ( HAPs) Test Rule.'' ( June 25, 1996). 2. The HAP Task Force. Letter from Peter E. Voytek to Charles M. Auer with attachment entitled: `` Proposal for Pharmacokinetics Study of Ethylene Dichloride, November 22, 1996.'' ( November 22, 1996). 3. U. S. EPA. Letter from Charles M. Auer to Peter E. Voytek with attachment entitled: `` Preliminary EPA Technical Analysis of Proposed Industry Pharmacokinetics ( PK) Strategy for Ethylene Dichloride, June, 1997.'' ( June 26, 1997). 4. The HAP Task Force. Letter from Peter E. Voytek to Charles M. Auer, U. S. EPA. ( March 19, 1999). 5. U. S. EPA. Letter from Charles M. Auer to Peter E. Voytek, HAP Task Force, Re: ECA Development of Ethylene Dichloride ( EDC) ( OPPTS 42197C, with attachment: `` EDC ECA   DRAFT, dated February, 2001.'' ( February 13, 2001). 6. Final Enforceable Consent Agreement for Ethylene Dichloride and Accompanying Testing Consent Order, signed by EPA on May 13, 2003. 7. D'Souza, R. W., Francis, W. R., Bruce R. D., and Andersen, M. E. Physiologically based phamacokinetic model for ethylene dichloride and its application in risk assessment. Pp 286   301, In: Pharmacokinetics in Risk Assessment. National Academy Press. Washington, D. C. ( 1987). 8. D'Souza, R. W., Francis, W. R., and Andersen, M. E. Physiological model for tissue glutathione depletion and increased resynthesis after ethylene dichloride exposure. Journal of Pharmacology and Experimental Therapeutics 245( 2): 563   568. 1988. 9. Daniel, F. B., Robinson, M., Olson, G. R., York, R. G., and Condie, L. W. Ten and ninety day toxicity studies of 1,2 dichloroethane in Sprague Dawley rats. Drug and Chemical Toxicology 17: 463   477. 1994. 10. Alumot, E., Nachtomi, E., Mandel, E., Holstein, P., Bondi, A., and Herzberg, M. Tolerance and acceptable daily intake of chlorinated fumigants in the rat diet. Food, Cosmetics and Toxicology 14: 105   110. ( 1976). 11. Rao, K. S., Murray, J. S., Deacon, M. M., John, J. A., Calhoun, L. L., and Young, J. T. Teratogenicity and reproduction studies in animals inhaling ethylene dichloride. Banbury Report 5: 149   166. ( 1980). 12. Lane, R. W., Riddle, B. L., and Borzelleca, J. F. Effects of 1,2 dichloroethane and 1,1,1 trichloroethane in drinking water on reproduction and development in mice. Toxicology and Applied Pharmacology 63: 409   421. 1982. 13. Payan, J. P., Saillenfait, A. M., Bonnet, P., Fabry, J. P., Langonne, I., and Sabate J. P. Assessment of the developmental toxicity and placental transfer of the 1,2 dichloroethane in rats. Fundamental and Applied Toxicology 28: 187   198. 1995. 14. Sherwood, R. L., O'Shea, W., Thomas, P. T., Ratajczak, H. V., and Aranyi, C. Effects of inhalation of ethylene dichloride on pulmonary defenses of mice and rats. Toxicology and Applied Pharmacology 91: 491   496. 1987. 15. U. S. EPA, OPPTS. `` Burden Estimates for the Enforceable Consent Agreement for Ethylene Dichloride.'' ( January 31, 2002).

List of Subjects Environmental protection, Hazardous chemicals.

Dated: May 13, 2003. Stephen Johnson, Assistant Administrator for Prevention, Pesticides and Toxic Substances.

[ FR Doc. 03   13721 Filed 6   2   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPPT   2002   0067; FRL   7287   4]

TSCA Section 8( e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: EPA is hereby finalizing revisions to certain parts of EPA's `` Statement of Interpretation and Enforcement Policy; Notification of Substantial Risk'' ( policy statement) issued March 16, 1978, concerning the reporting of `` substantial risk'' information pursuant to section 8( e) of the Toxic Substances Control Act ( TSCA). EPA is making these revisions after having considered public comments that were solicited in 1993 and 1995. Specifically, the revisions address the reporting of information on the release of chemical substances to, and the detection of chemical substances in, environmental media, the reporting deadline for written `` substantial risk'' information, and the circumstances under which certain information need not be reported to EPA under section 8( e) of TSCA. EPA is republishing the policy statement in its entirety in this document, including both those portions of the policy statement that are revised and those portions that are not affected by any revisions. Since the policy statement was published in 1978, this republication is intended to ensure that a single reference source for the TSCA section 8( e) policy and guidance is easily available to the regulated community and other interested parties. FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Director, Environmental Assistance Division ( 7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 554   1404; e mail address: TSCAHotline epa. gov. For technical information contact: Richard Hefter, Chief, High Production Volume Chemicals Branch, Risk Assessment Division, Office Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 564   7649; e mail address: hefter. richard@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you manufacture, process, import, or distribute in commerce chemical substances and mixtures. Potentially affected entities may include, but are not limited to:   Chemical manufacturers, processors, and distributors ( NAICS 325)   Petroleum refiners and distributors ( NAICS 324)   Manufacturers of plastic parts and components ( NAICS 325211)   Paints and coatings and adhesive manufacturing ( NAICS 3255)   Cleaning compounds and similar products manufacturing ( NAICS 3256)   Electronics manufacturing ( NAICS 334 and 335)   Automobiles manufacturing ( NAICS 3361)

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[Federal Register: December 17, 2008 (Volume 73, Number 243)]
[Notices]
[Page 76689-76690]
[DOCID:fr17de08-121]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59072; File No. SR-ISE-2008-92]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change as Modified by Amendment No. 1 Thereto Relating to Cancellation
Fees

December 10, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 28, 2008, the International Securities Exchange, LLC
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the ISE.
On December 9, 2008, the ISE filed Amendment No. 1 to the proposed rule
change. The Commission is publishing this notice to solicit comments on
the proposed rule change, as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its Schedule of Fees regarding its
cancellation fee. The text of the proposed rule change is available on
the Exchange's Web site (http://www.ise.com), at the principal office
of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this proposed rule change is to amend the ISE's
cancellation fee. The Exchange currently has a cancellation fee of
$2.00 that applies to Electronic Access Members (``EAMs'') that
cancelled at least 500 orders in a month, for each order cancellation
in excess of the total number of orders such member executed that
month. Further, all orders from the same clearing EAM executed in the
same underlying symbol at the same price within a 30 second period are
aggregated and counted as one executed order for purposes of this fee.
This fee is currently charged only to customer orders; broker-dealer
orders, including non-member market maker (FARMM) orders, are excluded
from this fee.
    Historically, some customers sought to avoid the cancellation fee
by executing large quantities of small orders in inexpensive, out of
the money options to offset their cancellation

activity in actively traded, at the money strikes where they conduct
the majority of their profitable business. In response, the Exchange
adopted a 30 second aggregation window when calculating the fee,
wherein all orders executed by the same clearing customer of a Member
firm, in the same underlying symbol and at the same price within 30
seconds are aggregated and counted as one execution.\3\ While adopting
the 30 second window reduced the incentive for these customers to enter
multiple orders in rapid succession at the same price and, at that
time, in the same series,\4\ cancelled orders continued to be an issue.
Additionally, the recent downturn in the market has resulted in
thousands of out of the money options across hundreds of symbols,
creating new opportunities for some customers to enter small orders at
different price levels during the 30 second time period, allowing for
more cancellation activity in at the money strikes.
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    \3\ See Securities Exchange Act Release No. 53862 (May 24,
2006), 71 FR 31244 (June 1, 2006).
    \4\ Earlier this year, in SR-ISE-2008-81, ISE amended the manner
in which it calculates the fee by aggregating orders in the same
underlying symbol in place of aggregating orders in the same series.
See Securities Exchange Act Release No. 58898 (November 4, 2008), 73
FR 67238 (November 13, 2008).
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    Recognizing that order cancels and trades often happen in large
numbers, the purpose of this fee is to focus on activity that is truly
excessive and uses bandwidth and system capacity while fairly
allocating costs among Members. The Exchange has made efforts in the
past to recover system capacity and bandwidth costs relative to the
level of cancel and order entry activity by periodically raising its
cancellation fee.\5\ Despite these efforts, the level of canceled
orders continues to remain high, being offset by small order activity
in deep out of the money options. This in turn has further increased
capacity and bandwidth demands. As a result, ISE's receipt of cancel
fees has been reduced to a level where they no longer represent a fair
share of the Exchange's capacity costs.
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    \5\ See Securities Exchange Act Release Nos. 54321 (August 15,
2006), 71 FR 49496 (August 23, 2006); 55422 (March 8, 2007), 72 FR
12645 (March 16, 2007); 57467 (March 11, 2008), 73 FR 14291 (March
17, 2008); and 58692 (September 30, 2008), 73 FR 59006 (October 8,
2008).
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    In order to ease system congestion caused by cancelled orders, the
Exchange proposes to amend the manner by which it calculates its
current cancel fee by extending the current 30 second window to 300
seconds. ISE believes that extending the aggregation window to five
minutes will result in a reduction in the number of orders that are
sent to the Exchange to create offsetting trades.
    The Exchange believes this proposed fee change is justified to
address the level of cancellation activity and its effect on system
congestion. This proposed fee change will be operative on December 1,
2008.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(4) that an exchange have an equitable
allocation of reasonable dues, fees and other charges among its members
and other persons using its facilities. In particular, the Exchange
believes amending the 30 second window to 300 seconds is necessary to
address the current level of cancellation activity and its effect on
system congestion.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change establishes or changes a
due, fee, or other charge imposed by the Exchange, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \6\ and Rule 19b-
4(f)(2) \7\ thereunder. At any time within 60 days of the filing of the
proposed rule change the Commission may summarily abrogate such
proposed rule change if it appears to the Commission that such action
is necessary or appropriate in the public interest, for the protection
of investors, or otherwise in furtherance of the purposes of the
Act.\8\
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    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 19b-4(f)(2).
    \8\ For purposes of calculating the sixty-day abrogation period,
the Commission considers the period to commence on December 9, 2008,
the date on which the Exchange filed Amendment No. 1.
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2008-92 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2008-92. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.

All submissions should refer to File Number SR-ISE-2008-92 and should
be submitted on or before January 7, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-29902 Filed 12-16-08; 8:45 am]

BILLING CODE 8011-01-P