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Note: EPA no longer updates this information, but it may be useful as a reference or resource.


POSSIBLE TIMELINES AND KEY FEATURES OF THE
ENDOCRINE DISRUPTOR SCREENING AND TESTING PROGRAM
AND THE REMAINDER OF THE EDSTAC PROCESS

DRAFT TIMELINE FOR THE REMAINDER OF THE EDSTAC PROCESS

December 2-3, 1997

Sixth EDSTAC Plenary

December 1997

Meetings of EDSTAC Work Groups and Writing Teams aimed at January 1998 producing and distributing a comprehensive draft of the EDSTAC Interim/Draft Final? Report by no later than January 21, 1998.

(The choice between producing an Interim Report versus Draft Final Report may depend, in part, on whether one chooses the more optimistic or pessimistic post-EDSTAC timeline scenario.)

February 2-3, 1998

Seventh EDSTAC Plenary

February 9, 1998

EPA initiates six month formal internal review process, that will occur in parallel with the remainder of the EDSTAC process, in preparation for August 8, 1998 Federal Register notice.

OPTIMISTIC SCENARIO ONLY

EPA initiates effort to standardize and validate the High Through-Put Screening (HTPS) assays and the Tier 1 Screening (T1S) battery.

March 6, 1998

Deadline for submission of EDSTAC product to SAB/SAP Peer Review and public comment.

April 1998

If Interim Report option is selected, meetings of EDSTAC Work

May 1998

Groups and Writing Teams, as needed, to produce and distribute a comprehensive draft of the EDSTAC final report by no later than June 1, 1998.

May 5-6, 1998

SAB/SAP Peer Review Meeting

June 1, 1998

EPA completes effort to standardize and validate the HTPS component of the Endocrine Disruptor Screening and Testing Program (EDSTP).

June 17-18, 1998

Tentative Date for Eighth and Final EDSTAC Plenary
(The goal of this final meeting will depend on whether the EDSTAC is on the verge of achieving a consensus, as well as whether one chooses the more optimistic or pessimistic post-EDSTAC timeline scenario.)

July 1, 1998

EDSTAC completes its work on a Final Report and formally conveys the report to EPA.

THE MORE OPTIMISTIC POST-EDSTAC SCENARIO

August 3, 1998

EPA completes internal review process and formally proposes its planned approach to the EDSTP through a notice in the Federal Register and initiates a formal 60-day public comment period.

EPA initiates negotiation with industry, with appropriate involvement from other stakeholder groups, on a Cooperative Research and Development Agreement (CRADA) or consent agreement to implement HTPS (under the assumption that industry collects and assures the quality of chemical samples and EPA contracts with a lab to conduct the HTPS).

October 1, 1998

Signed agreement between EPA and industry for undertaking the HTPS step of the process. Industry initiates six month effort to collect and assure quality of chemical samples that will be subjected to HTPS.

November 1, 1998

Deadline for receipt of public comments on EPA Proposed EDSTP.

January 1, 1999

EPA announces its responses to public comment and final decisions on the EDSTP.

March 1, 1999

EPA completes the standardization and validation efforts for the Tier 1 Screening battery.

April 1, 1999

Industry completes collection and quality assurance of chemical samples for HTPS. EPA (through a contract lab) initiates final step in the HTPS part of the process.

June 1, 1999

EPA (through a contract lab) completes the HTPS and begins to take steps to incorporate the results into the EDSTP priority setting system.

August 1, 1999

EPA formally initiates Phase I of the EDSTP by announcing in the Federal Register and initiating a formal 60-day public comment period on

a) the results of the T1S validation;
b) the results of the HTPS; and
c) EPA's priority setting decisions (i.e., "the list" of chemicals that EPA is proposing be subjected to T1S in Phase I and all subsequent phases of the program).

October 1, 1999

Deadline for receipt of public comments that would include reactions to the list, receipt of data that could result in a change in priority, nominations for chemicals that were not included on the list or lists, etc.

December 1, 1999

EPA announces its final decisions on the list of chemicals that will be subjected to T1S during Phase I and subsequent phases and simultaneously issues orders (under its FQPA authority) to the "owners" of those chemicals that can be subjected to orders to ensure compliance with the requirement for T1S.

Where appropriate, EPA also issues "data call-ins" for pesticides that may not need to be subjected to T1S, but would still require some elements of Tier 2 Testing (T2T).

Finally, EPA initiates internal process to develop a draft TSCA Test Rule (and/or consent agreements) to address the need for T1S for chemicals that the agency does not have clear authority to issue orders under the FQPA and SDWA.

December 1, 2000

EPA publishes draft TSCA Test Rule (and/or consent agreements).

December 1, 2001

EPA publishes final TSCA Test Rule (and/or consent agreements) and moves forward with T1S for chemicals that have received a high priority score for Phase II or subsequent phases, and for which EPA does not have authority to order T1S absent a final TSCA Test Rule.

THE MORE PESSIMISTIC POST-EDSTAC SCENARIO

August 3, 1998

EPA initiates effort to standardize and validate both the HTPS assays (estimated to take eight months, rather than four months in the optimistic scenario) and the T1S battery (estimated to take two years, rather than one year in the optimistic scenario). (Also note, under the optimistic scenario the validation efforts start in February 1998, prior to the completion of both the EDSTAC process and the SAB/SAP peer review, rather than August 1998). EPA completes internal review process and formally proposes its planned approach to the Endocrine Disruptor Screening and Testing Program (EDSTP) through a notice in the Federal Register and initiates a formal 60-day public comment period.

November 1, 1998

Deadline for receipt of public comments on EPA Proposed EDSTP. January 1, 1999 EPA announces its responses to public comment and final decisions on the EDSTP. April 1, 1999 EPA completes effort to standardize and validate the HTPS component of the EDSTP. EPA initiates negotiation with industry, with appropriate involvement of other stakeholder groups, on a Cooperative Research and Development Agreement (CRADA) or consent agreement to implement HTPS (under the assumption that industry collects and assures the quality of chemical samples and EPA contracts with a lab to conduct the HTPS).

June 1, 1999

Signed agreement between EPA and industry for undertaking the HTPS step of the process. Industry initiates six month effort to collect and assure quality of chemical samples that will be subjected to HTPS.

December 1, 1999

Industry completes collection and quality assurance of chemical samples for HTPS. EPA (through a contract lab) initiates final step in the HTPS part of the process.

February 1, 2000

EPA (through a contract lab) completes the HTPS and begins to take steps to incorporate the results into the EDSTP priority setting system.

March 1, 2000

EPA announces in the Federal Register and initiates a formal 60-day public comment period on: a) the results of the HTPS; and b) EPA's priority setting decisions (i.e., "the list" of chemicals that EPA is proposing be subjected to T1S in Phase I and all subsequent phases of the program).

May 1, 2000

Deadline for receipt of public comments that would include reactions to the list, receipt of data that could result in a change in priority, nominations for chemicals that were not included on the list or lists, etc.

August 1, 2000

EPA completes the standardization and validation efforts for the Tier 1 Screening battery. September 1, 2000 EPA announces in the Federal Register the results of the T1S validation process along with its final decisions on the list of chemicals that will be subjected to T1S during Phase I and subsequent phases. EPA issues orders (under its FQPA authority) to the "owners" of those chemicals that can be subjected to orders to ensure compliance with the requirement for T1S. Where appropriate, EPA also issues "data call-ins" for pesticides that may not need to be subjected to T1S, but would still require some elements of Tier 2 Testing (T2T). Finally, EPA initiates internal process to develop a draft TSCA Test Rule (and/or consent agreements) to address the need for T1S for chemicals that the agency does not have clear authority to issue orders under the FQPA and SDWA. March 1, 2002 EPA publishes draft TSCA Test Rule (and/or consent agreements). September 1, 2003 EPA publishes final TSCA Test Rule (and/or consent agreements) and moves forward with T1S for chemicals that have received a high priority score for Phase II or subsequent phases, and for which EPA does not have authority to order T1S absent a final TSCA Test Rule.


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