EPA Reaches Agreement in Principle with NRDC 

26jan01

EPA and the Natural Resources Defense Council (NRDC) have entered into two agreements to settle pending lawsuits. NRDC and others had filed lawsuits regarding implementation of the Food Quality Protection Act of 1996 (FQPA) and the 1988 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) concerning the reregistration of pesticides. 

The first agreement [ see CONSENT DECREE ] resolves claims related to EPA's compliance with deadlines for tolerance reassessment and reregistration.  NRDC and EPA filed a motion in the United States District Court for the Northern District of California, on January 19, 2001, asking the court to enter the agreement as a Consent Decree.  If entered by the District Court, the terms of the consent decree will create court enforceable deadlines for EPA actions.

The second agreement [ see SETTLEMENT  AGREEMENT ] is a settlement agreement that resolves claims related to EPA's compliance with deadlines for implementing an endocrine disruptor screening program, but, unlike the first agreement, it would not subject EPA to potential judicial enforcement.

In the proposed consent decree, EPA is agreeing to deadlines for conducting a cumulative risk assessment for organophosphate pesticides and risk assessments or risk management decisions for eleven pesticides.  This agreement is consistent with EPA strategy regarding FQPA implementation, and does not change the pesticide reregistration or tolerance reassessment procedures or priorities. Moreover, the focused scope of the agreement and the flexibility provided EPA in meeting the deadlines assure minimal disruption to its pesticide regulatory responsibilities.

In the settlement agreement, EPA agrees to flexible target dates for:

1. completing development of a data base that the Agency will use to prioritize chemicals for screening in the Endocrine Disruptor Screening Program,

2. completing validation of the screens and tests that are part of the Program, and

3. starting to require screening and testing of chemicals under the Program.

EPA was sued collectively by NRDC, The Breast Cancer Fund (TBCF), CalPIRG Charitable Trust (CalPIRG-CT), Pesticide Watch Education Fund (PWEF). Pesticide Action Network North American Regional Center (PANNA), San Francisco Bay Area Physicians for Social Responsibility, and United Farm Workers of America, AFL-CIO.  In two separate actions, NRDC and others challenged EPA's compliance with deadlines for tolerance reassessment and reregistration and implementing an endocrine disruptor screening program.  The American Crop Protection Association (ACPA) and the Farm Bureau intervened in both cases.  The American Chemistry Council (ACC) and People for the Ethical Treatment of Animals (PETA) intervened only in the District Court case pertaining to endocrine disruptor screening.

(Text versions of Consent Decree and Settlement Agreement are attached. For a copy of the signed version, please contact the Communication Services Branch in the Office of Pesticide Programs at 703-305-5017)

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UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF CALIFORNIA
SAN FRANCISCO DIVISION
NATURAL RESOURCES DEFENSE  COUNCIL, et al.,                                

Plaintiffs,

v.

CAROL M. BROWNER, Administrator of the United States Environmental Protection Agency, et al.,

Defendants.
)
)
) Case No. C-99-3701 CAL
)
)
      AMERICAN FARM BUREAU
      FEDERATION, et al.,

      Intervenors. )
)
)
     PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS, et al.,

            Intervenors.)
)
)

PARTIAL CONSENT DECREE WHEREAS, the Natural Resources Defense Council (NRDC), The Breast Cancer Fund (TBCF), CalPIRG Charitable Trust (CalPIRG CT), Pesticide Watch Education Fund (PWEF), Pesticide Action Network North American Regional Center (PANNA), San Francisco Bay Area Physicians for Social Responsibility, and United Farm Workers of America, AFL CIO (collectively "Plaintiffs") commenced this action for declaratory and injunctive relief pursuant to, inter alia, the Administrative Procedure Act ("APA"), 5 U.S.C.  551, et seq., on August 3, 1999, against Defendants Carol Browner, Administrator of the Environmental Protection Agency, and the Environmental Protection Agency (collectively, "EPA");

WHEREAS, Plaintiffs amended their complaint on February 8, 2000, EPA filed an answer to the amended complaint on March 10, 2000, and EPA amended its answer on March 30, 2000;

WHEREAS, Plaintiffs allege that EPA has failed to meet statutory deadlines for regulatory action mandated by the Federal Food, Drug and Cosmetics Act ("FFDCA"), including the reassessment of pesticide tolerances pursuant to FFDCA section 408(q), 21 U.S.C.  346a(q), and the implementation of an Endocrine Disruptors Screening and Testing Program pursuant to FFDCA section 408(p), 21 U.S.C.  346a(p);

WHEREAS, the APA provides for judicial review of agency action made reviewable by statute or final agency action for which there is no other adequate remedy in court to determine whether such action is arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law, or unlawfully withheld or unreasonably delayed, 5 U.S.C.  704,706;

WHEREAS, certain Plaintiffs have also filed, on August 3, 1999, a petition for review, United Farm Workers of America, AFL-CIO, et al. v. Browner, No. 99-70946 (9th Cir.) ("United Farm Workers"), alleging that EPA has unlawfully failed to complete the reregistration of pesticides pursuant to the Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C.  136a-1;

WHEREAS, EPA continues to dispute Plaintiffs' allegations;

WHEREAS, EPA intends to comply with its obligations in FIFRA section 17(b) to transmit notices of pesticide cancellations and suspensions, including, but not limited to, cancellations or suspensions under section 6 of FIFRA,  to governments of other countries and appropriate international agencies;

WHEREAS, Plaintiffs and EPA have agreed to a settlement of the claims raised in Counts 1 through 5 of this Action without any admission of fact or law, which they consider to be a just, fair, adequate and equitable resolution of the claims raised in this action;

WHEREAS, Plaintiffs and EPA have agreed to a settlement of the claims raised in Count 6 of this Action, which settlement is embodied in a separate settlement agreement, which is not a part of this Consent Decree;

WHEREAS, Plaintiffs believe the activities required in this Consent Decree are among the highest priorities for EPA to address in the FIFRA reregistration and FFDCA tolerance reassessment programs;

WHEREAS, Plaintiffs have also agreed to the withdrawal of their petition for review in United Farm Workers;

WHEREAS, by entering into this Consent Decree, Plaintiffs and EPA do not waive or limit any claim or defense, on any grounds, related to any agency action that may ensue from EPA's performance of its obligations under this Consent Decree;

WHEREAS, it is in the interest of the public, the parties and judicial economy to resolve the issues in this action without protracted litigation; and

WHEREAS, the Court finds and determines that this Consent Decree represents a just, fair, adequate and equitable resolution of the claims raised in this action;

NOW, THEREFORE, it is hereby ordered, adjudged, and decreed as follows:

I.  PARTIES

1. The parties to this Consent Decree are Plaintiffs and EPA.

II.  PARTIES BOUND

2. This Consent Decree applies to, is binding upon, and inures to the benefit of Plaintiffs (and their successors, assigns, and designees) and EPA.

III.  DEFINITIONS

3. Unless otherwise expressly provided, the terms used in this Consent Decree shall have the meaning, if any, assigned to them by FIFRA or the FFDCA as of the date of entry of this Consent Decree or as subsequently amended.  The following definitions shall apply to the terms identified below:

A.  General Terms

B.  Terms Related to Tolerance Reassessment

"Organophosphate Pesticides" means the 39 chemicals identified on the list attached to this Consent Decree as Appendix A, which is incorporated herein by reference. "Reregistration Eligibility Determination" or "RED" means a document containing EPA's determination as to whether pesticides containing an active ingredient are eligible for reregistration pursuant to section 4(g)(2)(A) of FIFRA and EPA's determination as to whether the associated tolerances meet the standard set forth in section 408(b) of the FFDCA. "Interim RED" means a document containing EPA's determination as to whether pesticides containing an active ingredient are eligible for reregistration pursuant to section 4(g)(2)(A) of FIFRA and EPA's determination, without consideration of any cumulative effects of the pesticide and other substances that have a common mechanism of toxicity, as to whether the associated tolerances would meet the standard set forth in FFDCA 408(b). "Revised Risk Assessment" means a risk assessment completed after release to the public of a preliminary risk assessment and the consideration of public comment on the preliminary risk assessment.

IV.  REASSESSMENT OBLIGATIONS 

A.  Conduct of the Organophosphate Risk Assessment

4. EPA shall issue a preliminary risk assessment by December 1, 2001 for cumulative effects of the 39 Organophosphate Pesticides.  Within two hundred and forty (240) days of the issuance of the preliminary risk assessment or August 3, 2002, whichever is later, EPA shall issue a revised  risk assessment.  In conducting this preliminary and revised risk assessment, EPA shall consider cumulative effects of  the Organophosphate Pesticides and other factors to the extent required by FFDCA  408(b).   In conducting these risk assessments, EPA will take into account the written report from the September 26-29, 2000 meeting of the FIFRA Scientific Advisory Panel (SAP) and the oral comments by the SAP during the December 7-8, 2000 meeting and any subsequent written report from that meeting.  Nothing in this Paragraph shall limit or modify EPA's discretion to disagree with the SAP's conclusions.   

5. Notwithstanding Paragraph 4, EPA shall be excused from compliance with the deadlines in Paragraph 4 if EPA encounters substantial scientific difficulties in conducting the risk assessment described therein.  Substantial scientific difficulties shall be deemed to be present only if a future report of the SAP advises EPA that either (1) the premises underlying EPA's  risk assessment of Organophosphate Pesticides are significantly flawed or (2) the methodology for conducting the risk assessment is significantly flawed.  Significantly flawed means flawed to such an extent that EPA determines that its risk assessment approach, or resource commitment to conduct such risk assessment, must be fundamentally altered.  If EPA determines that it has encountered substantial scientific difficulties as set forth in this Paragraph, EPA shall, within ninety (90) days of issuance of the relevant SAP report, provide to Plaintiffs in writing a notice that substantial scientific difficulties have been encountered, an explanation of the bases therefor, and a reasonable schedule for completing a preliminary and/or revised risk assessment in light of the SAP report and the issues raised therein.  For the purposes of this Paragraph, it shall be presumed that any schedule of up to one additional year is  reasonable; EPA bears the burden of overcoming this presumption for any schedule longer than one additional year.  Any schedule adopted pursuant to this Paragraph shall be enforceable under all the applicable provisions of this Consent Decree.  If Plaintiffs disagree either with the determination that substantial scientific difficulties have been encountered or with the reasonableness of the schedule,  Plaintiffs may invoke the Dispute Resolution provision in Paragraph 23 of this Consent Decree.

6. Plaintiffs' entry into this Consent Decree does not imply in any way their acquiescence in the manner in which EPA performs the risk assessment for cumulative exposure to Organophosphate Pesticides.  Plaintiffs expressly reserve all of their rights to challenge, in a separate action, any EPA final actions based on such risk assessment including challenging the validity of the risk assessment. EPA expressly reserves any and all defenses to any such challenge, including lack of jurisdiction.

B.  Revised Risk Assessments and REDs

7. For each of the pesticides listed in this Paragraph, EPA shall, by the dates set
forth herein, sign a RED, interim RED or revised risk assessment, as specified below.  The interim RED and revised risk assessment will consider aggregate exposure to the pesticide, taking into account the validity, completeness, and reliability of the available data; however, EPA will not be required to consider any cumulative effects due to the pesticide's sharing a common mechanism of toxicity, in an interim RED or revised risk assessment issued under this Paragraph.   In addition, the interim RED and revised risk assessment will consider potential worker and ecological risks posed by the pesticide.  If, in the course of preparing a RED pursuant to the schedule below, EPA determines that available information shows it would be appropriate to assess the cumulative effects of the listed pesticide and other substances that have a common mechanism of toxicity, EPA will not be required by this Consent Decree to complete a RED by the specified date, and will instead complete an interim RED by that date.

Pesticide Date Type of action

phosmet April 30, 2001 Interim RED azinphos-methyl August 31, 2001 Interim RED propargite September 30, 2001 RED chlorpyrifos September 30, 2001 Interim RED atrazine August 3, 2002 Interim RED carbaryl June 30, 2003 Interim RED benomyl July 31, 2002 RED endosulfan July 31, 2002 RED lindane July 31, 2002 RED diazinon July 31, 2002 Interim RED metam sodium August 31, 2004 Revised Risk Assessment

As to the August 31, 2004 date for the metam sodium revised risk assessment, EPA shall proceed at an earlier date if significant, new information indicates that the risks are substantially greater than the risks that are known to EPA at the effective date of this Consent Decree.  Any EPA determination regarding the timing of the metam sodium revised risk assessment is entitled to deference.

C.  Post-Interim RED Actions for Certain Pesticides

8

For each of the pesticides azinphos-methyl, chlorpyrifos, and diazinon, EPA will include in the Interim RED published pursuant to Paragraph 7 a determination, whether any use of the pesticide poses risks to workers that constitute unreasonable adverse effects on the environment.  If EPA finds the pesticide poses such risks, EPA shall also include in the RED, at EPA's sole discretion, a determination whether such risks require relatively quick regulatory action or can likely be acceptably mitigated through more routine changes to a pesticide's labeling or formulation.  If EPA determines that relatively quick regulatory action is appropriate, EPA will provide a draft notice of intent to cancel (NOIC) designed to eliminate the unreasonable adverse effects on the environment related to worker risk to the SAP and the United States Department of Agriculture (USDA) no later than eight (8) months after the date the Interim RED is signed.  If EPA determines that the worker risks that constitute unreasonable adverse effects on the environment can likely be acceptably mitigated through more routine changes to a pesticide's labeling or formulation, EPA will provide a draft NOIC designed to eliminate such unreasonable adverse effects on the environment to the SAP and the USDA no later than 19 months after the date the Interim RED is signed.  The EPA's determination in Subparagraph (a) above, as to whether risks require relatively quick action or not, is not reviewable under this Consent Decree.  Plaintiffs reserve their right to challenge EPA's actions in a separate action under any applicable authority.  EPA reserves any and all defenses to any such challenge, including lack of jurisdiction. Notwithstanding any other provision of this Paragraph, if EPA determines that the unacceptable worker risks identified in the determination called for under this Paragraph will be substantially eliminated through implementation of an effective regulatory instrument that has been finalized before a draft NOIC is provided to the SAP and USDA, EPA shall not be obligated to issue a draft NOIC pursuant to this Paragraph and may instead elect to pursue any other appropriate regulatory means of dealing with any remaining unacceptable worker risks.  In such circumstances, EPA shall, on or before the date it would have been obligated to provide a draft NOIC to the SAP and USDA, notify the Plaintiffs in writing of its determination, the bases therefor, and, if any unacceptable worker risks remain, how the Agency intends to deal with such risks.  The Agency shall also provide such notification to the public in such manner as the Agency deems appropriate, including at a minimum either publication on the Office of Pesticide Programs' Internet Website Home Page or in the Federal Register.  Notwithstanding any other provision of this Paragraph, if EPA determines before a draft NOIC is provided to the SAP and USDA that new scientific information and/or a change in the way the Agency treats existing scientific information could significantly alter EPA's assessment of worker risks associated with the pesticide in a way that could significantly affect the basis for the draft NOIC, EPA may, on or before the date it would have been obligated to provide a draft NOIC to the SAP and USDA, issue a determination that it would be inappropriate to submit a draft NOIC to the SAP and USDA pursuant to the schedule that would otherwise be required pursuant to this Paragraph.  Such determination shall include, at a minimum, the bases for the determination and a proposed schedule for further action with respect to the pesticide. Such schedule shall include, at a minimum, a proposed date for determining whether, in light of the new information or practice, worker risks associated with the pesticide constitute unreasonable adverse effects on the environment and, if so, how the Agency intends to deal with such risks under the framework set forth in Subparagraph (a) of this Paragraph. EPA shall provide this determination in writing to the Plaintiffs, and EPA shall also make the determination available to the public in such manner as the Agency deems appropriate, including at a minimum either publication on the Office of Pesticide Programs' Internet Website Home Page or in the Federal Register.

D.  Common Mechanism of Toxicity Determinations  

9. For each group of pesticides listed in this Paragraph, EPA shall make a determination, by the specified date, as to whether the pesticides in the listed group share a common mechanism of toxicity.  Such determination will be publicly released through a memorandum signed by the Director of the Office of Pesticide Programs.  Nothing in this Consent Decree shall be construed to limit or modify EPA's discretion subsequently to change its conclusions regarding whether a group of pesticides listed herein shares a common mechanism of toxicity, whether based upon new data or upon reexamination of existing data. 

Pesticide Group/Subgroup Date

Carbamates: methyl carbamates June 30, 2001 thiocarbamates and dithiocarbamates December 31, 2001 Chloroacetanilides June 30, 2001 Triazines March 31, 2002

E.  Annual Reports

10. EPA shall prepare an annual report, as described below, beginning one year from the effective date of this Consent Decree.  This date shall be known as the "annual reporting date."  The obligation to publish an annual report shall cease once EPA meets its obligations under Subparagraphs (a) and (b) or August 3, 2006, whichever is sooner. The annual report shall be published by placing the report on the Office of Pesticide Programs' Internet Website.  The report shall be readily accessible from the Office of Pesticide Programs' Home Page.  The annual report shall contain the following:

Pesticides in Paragraph 7.  The annual report must address any pesticide in Paragraph 7 as to which (1) a RED or Interim RED has been issued at least three (3) months prior to the annual reporting date, and (2) the RED or Interim RED identifies at least one risk posed by the pesticide that may generally cause unreasonable adverse effects on the environment or concludes that at least one associated tolerance does not meet the requirements of FFDCA section 408(b).  For the annual report that is required after a pesticide is first identified under these criteria, the report shall contain the following information concerning the identified pesticide:  (1) a description of the risk(s) or tolerance(s) that meet the above criterion; and (2) a description of EPA's plan for addressing such risk(s) or tolerance(s).  Subsequent annual reports shall describe EPA's steps toward completion of its plan for addressing such risk(s) or tolerance(s).  The obligation to include a pesticide in the annual report shall end once EPA includes in the annual report its conclusion that such risk(s) or tolerance(s) have been addressed.  Pesticides in Paragraph 9.  The annual report must address any group or subgroup of  pesticides in Paragraph 9 as to which (1) EPA has determined that the pesticides in the group or subgroup share a common mechanism of toxicity, and (2) such determination has occurred at least six (6) months prior to the annual reporting date.  For the annual report that is required after a group or subgroup of pesticides is first identified under these criteria, the report shall contain the following information concerning the identified group or subgroup:  a schedule for the completion of both a preliminary and revised risk assessment on the pesticide group or subgroup.  Within six (6) months of completing the revised risk assessment for a pesticide group or subgroup, EPA shall make its best estimate of the schedule for completing the Interim REDs and/or REDs for the pesticides in that group or subgroup.  This schedule shall be included in the first annual report due following the issuance of the schedule.    No schedule made pursuant to this Paragraph shall  be binding on the EPA under this Consent Decree or under any other provision of law.  Subsequent annual reports shall describe EPA's steps toward completion of its schedules for completion of preliminary and revised risk assessments.  The obligation to include a pesticide group or subgroup in the annual report shall end once EPA includes in the annual report its conclusion that it has completed the REDs for the pesticides in the group or subgroup.

V.  WITHDRAWAL OF PETITION FOR REVIEW

11. Plaintiffs agree that this Consent Decree shall be Null and Void unless, within thirty (30) days after being served with the Court's order establishing the Effective Date of this Consent Decree, Petitioners in the United Farm Workers case have withdrawn their petition for review.  Further, this Consent Decree shall be Null and Void if any petitioner in United Farm Workers were to reinitiate that litigation prior to the date specified for completion of all activities required in Paragraph 7 (i.e., August 31, 2004).  If any deadline in Paragraph 7 should be extended by the Court, this Consent Decree shall be Null and Void if any petitioner in United Farm Workers were to reinitiate that litigation prior to the extended deadline ordered by the Court.  However, in no event shall this Consent Decree become Null and Void or otherwise affected by petitioners' reinitiating the United Farm Workers litigation after August 3, 2006.

VI.  CONTINUING JURISDICTION

12. For purposes of entry and enforcement of this Consent Decree only, the parties
to this Consent Decree agree that the Court has jurisdiction over this matter, the parties to the Consent Decree, any disputes arising under this Consent Decree, and any alleged violations of this Consent Decree, and may issue such further orders or direction as may be necessary or appropriate to construe, implement, modify or enforce the terms of this Consent Decree, and for granting any further relief as the interests of justice may require. 

VII.  REMEDY AND SCOPE OF JUDICIAL REVIEW

13. Nothing in this Consent Decree shall be construed to confer upon this Court jurisdiction to review any decision, either procedural or substantive, to be made by EPA pursuant to this Consent Decree, except for the purpose of determining EPA's compliance with this Consent Decree.

14. Plaintiffs' sole judicial remedy to address the merits of any final action that may ensue from EPA's performance of its obligations under this Consent Decree is to file a separate lawsuit challenging such final action.  EPA reserves all of its defenses to any such suit.  Nothing in this Consent Decree alters or affects the standards for judicial review of final EPA action, or creates jurisdiction that would otherwise not exist to review EPA action.

15. Plaintiffs agree that they will not seek to enforce any date for the performance of any obligation under this Consent Decree that is earlier than the date identified for such action in Paragraphs 4 through 10 of this Consent Decree, either pursuant to the FFDCA or any other authority.

VIII.  AGENCY DISCRETION

16. Except as expressly provided herein, nothing in this Consent Decree shall be construed to limit or modify the discretion accorded EPA by the FFDCA, FIFRA, the APA, or general principles of administrative law. 

17. Nothing in this Consent Decree shall bar EPA from acting on any matters covered in this Consent Decree in a time frame earlier than required by this Consent Decree or to take additional actions not specified herein if EPA determines such actions are appropriate under applicable law.

IX.  COMPLIANCE WITH OTHER LAWS

18. Nothing in this Consent Decree shall be interpreted as or constitute a commitment or requirement that EPA obligate or pay funds in contravention of the Anti-Deficiency Act, 31 U.S.C.  1341, or take any action in contravention of the FFDCA, FIFRA, the APA, or any other law or regulation, either substantive or procedural.

X.  MODIFICATION

19. Amendment of the deadlines in FIFRA section 4 or FFDCA section 408(q) shall supercede any deadlines in this Consent Decree.

20. This Consent Decree may be modified by written agreement of the Parties and approval of the Court.  Nothing in this Consent Decree, or in the Parties' agreement to its terms, shall be construed to limit the equitable powers of the Court to modify the terms of the Consent Decree upon a showing of good cause by any Party.  Good cause may include changes in the law or substantial cuts to EPA's budget.

21. Any dates set forth in this Consent Decree may be extended by written agreement of the Parties and notice to the Court.  In the event the Parties are not able to agree to an extension, either party may seek a modification of any date established in this Consent Decree in accordance with the following procedures:

If a Party files a motion requesting an extension of more than thirty (30) days of a date or dates established by this Consent Decree, provides notice to the other Party at least thirty (30) days prior to the date sought to be modified, and files the motion at least twenty (20) days prior to the date sought to be modified, then the filing of such motion shall, upon request, stay the date for which modification is sought.  Such stay shall remain in effect until the earlier of (i) a dispositive ruling by this Court on such motion, or (ii) the date sought in the motion. If a Party files a motion requesting an extension of thirty (30) days or less of a date or dates established by this Consent Decree, provides notice to the other Party at least seven (7) days prior to the date sought to be modified, and files the motion at least seven (7) days prior to the date sought to be modified, then the filing of such motion shall, upon request, stay the date for which modification is sought.  Such stay shall remain in effect until the earlier of (i) a dispositive ruling by this Court on such motion, or (ii) the date sought in the motion. If a Party seeking modification does not provide notice pursuant to Subparagraphs a. or b. above, that Party may move the Court for a stay of the date or dates for which modification is sought.  The Party seeking modification shall promptly give notice to the other Party of its intent to seek a modification and/or stay of the date sought to be modified.  The notice provided under this Subparagraph and any motion for stay shall demonstrate why the Party could not have utilized the notification procedures set forth in Subparagraphs a. or b. above. Any motion to modify a date established in this Consent Decree shall be accompanied by a motion for expedited consideration.  All Parties shall join in any motion for expedited consideration associated with a motion to modify filed in accordance with procedures set forth in Subparagraphs a. or b. above.

XI.  FORCE MAJEURE

22. The Parties recognize that performance under this Consent Decree is subject to fiscal and procurement laws and regulations of the United States which include, but are not limited to, the Anti-Deficiency Act, 31 U.S.C.  1341, et seq.  A force majeure event may arise, due to  circumstances outside the reasonable control of EPA, that could delay compliance with the obligations set forth in Paragraphs 4 through 10 of this Consent Decree.  Such force majeure events include, but are not limited to, a government shutdown, such as occurred in 1995 and 1996, a failure of Congress to renew maintenance fees under 7 U.S.C.  136a-1(i) without the provision of  comparable replacement funding, or catastrophic environmental events requiring immediate and/or time-consuming response by EPA.  Emergency exemptions under section 18 of FIFRA shall not constitute a force majeure event for purposes of this Paragraph.  Should a delay occur due to a force majeure event, any resulting failure to fulfill any obligations set forth herein shall not constitute a failure to comply with the terms of this Consent Decree, and any deadlines so affected shall be extended one day for each day of the delay.  As soon as possible under such circumstances, EPA will provide Plaintiffs with notice invoking the relief provided for under this Paragraph, and with an explanation of EPA's basis for invoking this relief.  EPA shall also provide Plaintiffs with reasonable notice of the termination of the force majeure event upon which EPA invoked this relief.  Any dispute regarding invocation of such relief shall be resolved in accordance with the dispute resolution provision of Paragraph 23 of this Consent Decree.

XII.  DISPUTE RESOLUTION

23. In the event of a disagreement between the Parties concerning the interpretation or performance of any aspect of this Consent Decree, the dissatisfied Party shall provide the other Party with written notice of the dispute and a request for negotiations.  The Parties shall meet and confer in order to attempt to resolve the dispute within (twenty) 20 days after receipt of the notice, or such time thereafter as is mutually agreed upon.  If the Parties are unable to resolve the dispute within thirty (30) days after receipt of the notice, or such time thereafter as is mutually agreed upon, then either Party may petition the Court to resolve the dispute.

XIII.  TERMINATION OF THIS CONSENT DECREE

24. This Consent Decree shall terminate after EPA has fulfilled its obligations under Paragraphs 4 through 10 of the Consent Decree.  Upon termination of this Consent Decree, this Action shall be dismissed with prejudice.  EPA shall file the appropriate notice with the Court so that the Clerk of the Court may close the file. 

XIV.  RELEASE

25. This Consent Decree constitutes a complete and final settlement and is in full satisfaction of all claims asserted by Plaintiffs in Counts 1 through 5 of this Action, and all claims that they could have asserted with respect to the allegations in Counts 1 through 5 in their Complaint.

XV.  ATTORNEYS' FEES AND COSTS

26. The Parties agree that EPA shall pay $40,000 to Plaintiffs for attorneys' fees and costs as a full and complete settlement of Plaintiffs' claims for attorneys' fees and costs in this action and in United Farm Workers.  EPA shall pay the above amount within 90 days of the effective date of this Consent Decree.

XVI.  APPLICABLE LAW

27. This Consent Decree shall be governed by and construed under the laws of the United States.

XVII.  MUTUAL DRAFTING

28. The Parties to this Consent Decree agree that this Consent Decree was jointly drafted by them.  Accordingly, the Parties agree that any and all rules of construction to the effect that ambiguity is construed against the drafting Party shall be inapplicable in any dispute concerning the terms, meaning, or interpretation of this Consent Decree.

XVIII.  ENTIRE AGREEMENT

29. This Consent Decree constitutes the entire agreement of the Parties in this case. All prior conversations, meetings, discussions, drafts and writings of any kind are specifically superceded by this Consent Decree.

XIX.  USE OF CONSENT DECREE

30. This Consent Decree shall not constitute an admission or evidence of any fact,
wrongdoing, misconduct, or liability on the part of the United States, including, without limitation, EPA, its officers, or any other person affiliated with it.

XX.  THIRD-PARTY BENEFICIARIES

31. Nothing in this Consent Decree shall be construed to make any other person or entity not executing this Consent Decree a third-party beneficiary to this Consent Decree.  The Parties consent to the form, substance and entry of this Consent Decree.

XXI.  EFFECTIVE DATE

32. This Consent Decree shall become effective upon the date of its entry by the Court.  If, for any reason, the Court does not enter this Consent Decree, the obligations set forth in this Consent Decree are null and void.

XXII.  NOTICE AND CORRESPONDENCE

33. Any notice, including correspondence, required or made with respect to this Consent Decree, shall be in writing, effective upon receipt, and sent to the following persons, or to such other person or persons as any Party may subsequently identify (in accordance with this provision) to the other Parties:

For Plaintiffs:

Fred Altshuler
Altshuler, Berzon, Nussbaum, Rubin & Demain
177 Post Street
Suite 300
San Francisco, CA  94108

Erik Olson
Natural Resources Defense Council
1200 New York Avenue, N.W., Suite 400
Washington, DC  20005

For EPA:

Assistant General Counsel for Pesticides
Pesticides and Toxics Law Office
Office of General Counsel (2333A)
United States Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, D.C. 20004\

Chief
Environmental Defense Section
Environment and Natural Resources Division
United States Department of Justice
P.O. Box 23986
Washington, D.C. 20026-3986
Attn:  DJ # 1-05728

XXIII.  COUNTERPARTS

34. This Consent Decree may be executed in any number of counterpart originals, each of which shall be deemed to constitute an original agreement, and all of which shall constitute one agreement.  The execution of one counterpart by any Party shall have the same force and effect as if that Party had signed all other counterparts.

XXIV.  REPRESENTATIVE AUTHORITY

35. Each undersigned representative of the Parties to this Consent Decree certifies that he or she is fully authorized to enter into and execute the terms and conditions of this Consent Decree, and to legally bind such Party to this Consent Decree.  By the signatures below, the Parties consent to entry of this Consent Decree.

FOR PLAINTIFFS:
FOR EPA:
SO ORDERED this _________ day of ___________________, 2001.
___________________________________
JAMES CHARLES A. LEGGE
UNITED STATES DISTRICT JUDGE ATTACHMENT A

ORGANOPHOSPHATE PESTICIDES

1. Acephate

2. Azinphos-methyl

3. Bensulide

4. Cadusafos

5. Chlorethoxyphos

6. Chlorpyrifos

7. Chlorpyrifos-methyl

8. Coumaphos

9. Diazinon

10. Dichlorovos (DDVP)

11. Dicrotophos

12. Dimethoate

13. Disulfoton

14. Ethion

15. Ethoprop

16. Ethyl parathion

17. Fenamiphos

18. Fenitrothion

19. Fenthion

20. Malathion

21. Methamidophos

22. Methidathion

23. Methyl-parathion

24. Mevinphos

25. Naled

26. Oxydemeton-methyl

27. Phorate

28. Phosalone

29. Phosmet

30. Phostebupirim

31. Pirimiphos-methyl

32. Propetamphos

33. Profenophos

34. Sulfotepp

35. Temephos

36. Terbufos

37. Tetrachlorvinphos

38. Tribufos

39. Trichlorfon
    
    

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SETTLEMENT AGREEMENT

Whereas, on August 3, 1999, plaintiffs Natural Resources Defense Council; The Breast Cancer Fund; CALPIRG Charitable Trust; Pesticide Watch Education Fund; Pesticide Action Network; San Francisco Bay Area Physicians for Social Responsibility; and United Farm Workers of America, AFL-CIO (collectively, " Plaintiffs") filed a complaint in the United States District Court for the Northern District of California (Case No. C-99-3701 CAL) against the United States Environmental Protection Agency ("EPA") and Carol Browner, the Administrator of EPA (collectively, "EPA") (Plaintiffs and EPA are "the Parties"), alleging, inter alia, that EPA has failed to meet a statutory deadline for implementation of the Estrogenic Substances Screening Program mandated in section 408(p) of  the Federal Food, Drug, and Cosmetics Act ("FFDCA"), as amended by the Food Quality Protection Act, 21 U.S.C.  346a(p);

Whereas, Plaintiffs sought, inter alia, to compel EPA to implement expeditiously an Endocrine Disruptor Screening Program that an EPA Federal Advisory Committee Act Committee, the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), recommended to EPA, as a means of complying with section 408(p) of the FFDCA;

Whereas, Plaintiffs alleged that this Court has jurisdiction over this claim;
Whereas, on February 18, 2000, Plaintiffs filed a First Amended Complaint in the above-captioned case, in which Count Six contained allegations similar to those described above;

Whereas, to ensure compliance with the requirements of FFDCA section 408(p), 21 U.S.C.  346a(p), EPA currently plans to continue to move forward in implementing the general tenets of the Endocrine Disruptor Screening Program (EDSP) as set forth in EPA's December 28, 1998, Federal Register Notice, Endocrine Disruptor Screening Program: Proposed Statement of Policy, 63 Fed. Reg. 71,542.  The general tenets of this program include (1) a prioritization process; (2) a Validation program; (3) Tier 1 screening; and (4) Tier 2 testing;

Whereas, as part of the program, EPA currently plans to address as part of the EDSP estrogenic, androgenic, and thyroid endpoints;

Whereas, EPA plans continually to consider the advisability of incorporating into the EDSP assessment of other endocrine endpoints as the science advances and assays become available;

Whereas, EPA currently intends to validate and include as part of the Program the following Tier 1 screens: ER/AR Binding, Steriodogenesis, Aromatase, Uterotrophic, Hershberger, Pubertal Female, Pubertal Male, In utero/lactation, Fish Reproduction Screen, Frog Thyroid; and the following Tier 2 tests: Mammalian Two-generation Assay, Avian, Fish, Amphibian, Invertebrate.

Whereas, EPA currently intends to follow an appropriate Validation program, as described in attachment A, when validating the screens and tests that are part of the program;

Whereas, consistent with the goals of this program, EPA will endeavor to (1) reduce the number of animals used in implementing the Endocrine Disruptor Screening Program (EDSP), (2) refine procedures to make animal tests used in the Program less painful or stressful, and (3) replace animals with non-animal systems, where scientifically appropriate;

Whereas, EPA continues to dispute Plaintiffs' allegations;

Whereas, the Parties wish to resolve Count Six of the First Amended Complaint;

Whereas, it is in the interest of the public, the Parties, and judicial economy to resolve this Count without further protracted litigation;

Whereas, the Parties have agreed to a settlement of Count Six without any admission or adjudication of any questions of fact or law,

Whereas, the Parties consider this settlement to be a just, fair, adequate and equitable resolution of the claims raised in Count Six;

NOW, THEREFORE, the Parties agree as follows: 

I.  GENERAL TERMS

1. This Settlement Agreement applies to, is binding upon, and inures to the benefit of the Parties, their successors, assigns, and designees.

II.  DEFINITIONS

2. For purposes of paragraphs 3 through 9 of this agreement,

1. Validation is the process by which the relevance and reliability of a test method are evaluated for the purpose of supporting a specific use.  Relevance is a determination that a test truly measures the phenomenon that it is intended to measure.  Reliability is an objective measure of a method's intra- and interlaboratory variability.

2. The Endocrine Disruptor Priority-Setting Database (EDPSD) is a database that EPA is constructing to assist it in prioritizing chemicals for Tier 1 screening the first assay phase of the Endocrine Disruptor Screening Program.  The EDPSD will allow EPA to group chemicals by common data elements (e.g., amount of releases to water, amount found in monitoring studies, reproductive effects information) so that EPA can compare chemicals on a consistent basis.

3. Quantitative Structure Activity Relationship (QSAR) is a mathematical equation that relates chemical structure to a physical or chemical property or biological activity of a chemical.

4. Tier 1 Screens are short term in vitro or in vivo assays to determine whether a chemical substance or mixture may interact with the endocrine system.

5. Tier 2 Tests are longer term assays designed to determine whether a chemical substance or mixture may cause endocrine-mediated effects and to identify, characterize , and quantify those effects.

6. The Mammalian Two-generation Assay is a test involving the mating and reproduction of two generations of offspring.  The purpose of the test is to determine the effects of a chemical substance or mixture on  mammalian fertility, development, and reproduction.

7. Validation Status Report means a report that contains very short, succinct statements as to (i) the dates validating laboratories started validation work on an assay; (ii) the dates EPA received data from the validating laboratories and whether EPA found the data acceptable; (iii) if EPA determined the data from any validating lab to be unacceptable, the reasons for that determination and the steps EPA has taken to resolve the issue; (iv) an estimation of when validation will be complete; and (v) reasons for any delay in not meeting deadlines in paragraph 7.

III.  ENDOCRINE DISRUPTOR SCREENING PROGRAM

3. EPA will use best efforts to complete development of the architecture of the Endocrine Disruptor Priority Setting Database by July 31, 2001. EPA will use best efforts to complete and validate the Quantitative Structure-Activity Relationship (QSAR) portion of the EDPSD by December 31, 2001.  EPA will use best effort to ensure that the EDPSD will be operational by May 31, 2002.  If at any time EPA anticipates that it will be unable to make the EDPSD operational by May 31, 2002, or if the EDPSD is not fully operational by May 31, 2002, it will notify the Plaintiffs and provide them semi-annual reports of its progress toward making the EDPSD operational. These reports will describe the reasons for the delay and provide an estimate of when the EDPSD will be operational.

4. EPA agrees to review any results or data that it receives from Japan related to its High Throughput Prescreening (HTPS) effort.  EPA will use best efforts to determine within one year from receipt of such results or data whether to incorporate them into the EDPSD.  EPA will not incorporate, inter alia, results that are not scientifically valid or not otherwise appropriate for inclusion into the EDPSD.

5. EPA will use best efforts to publish and solicit public comment on an initial list of chemicals for screening no later than December 31, 2002.  If at any time EPA anticipates that it will be unable to publish such a list by December 31, 2002, or if it fails to publish such a list by December 31, 2002, it will notify the Plaintiffs and provide them with semi-annual reports of its progress toward publishing such a list.  These reports will describe the reasons for the delay and provide an estimate of when EPA will publish such a list.

6. EPA currently intends to validate and include as part of the EDSP the following Tier 1 screens: ER/AR Binding, Steriodogenesis, Aromatase, Uterotrophic, Hershberger, Pubertal Female, Pubertal Male, In utero/lactation, Fish Reproduction Screen, Frog Thyroid; and the following Tier 2 tests: Mammalian Two-generation Assay, Avian, Fish, Amphibian, Invertebrate.   However, nothing in this settlement agreement shall be construed as limiting or modifying EPA's discretion to add to, subtract from, vary from, or modify the screens or tests that it includes in Tier 1 and Tier 2.

7. EPA will use best efforts to complete Validation of all of the Tier 1 screens except the Frog Thyroid assay no later than December 31, 2003.   EPA will use best efforts to complete validation of the Frog Thyroid assay.  EPA will determine whether to include it as part of Tier 1 by December 31, 2002.  If the Frog Thyroid assay proves not to be valid and/or EPA decides not to include it in the EDSP, EPA will use best efforts to identify in a timely manner another assay that will cover the thyroid endpoint that it was intended to cover, including but not limited to assays already included in Tier 1.  EPA will use best efforts to complete Validation of the Tier 2 Mammalian Two-generation Assay no later than December 31, 2004.  EPA will use best efforts to complete Validation of  certain other Tier 2 tests listed in, and subject to the second sentence of, paragraph 6 no later than December 31, 2005.  If at any time EPA anticipates that it will be unable to complete Validation by any of these dates, or if it fails to complete Validation by these dates, it will notify Plaintiffs and provide them with semi-annual Validation Status Reports of its progress toward completing Validation.

8. EPA will use best efforts to start requiring testing, using appropriate regulatory mechanisms, for certain Tier 1 screens listed in, and subject to the second sentence of, paragraph 6 no later than December 31, 2003.  EPA will use best efforts to start requiring testing, using appropriate regulatory mechanisms, for certain Tier 2 tests listed in, and subject to the second sentence of, paragraph 6 no later than December 31, 2004.  If at any time EPA anticipates that it will be unable to start requiring testing by any of these dates, or if it fails to require testing by any of these dates, it will notify Plaintiffs and provide them with semi-annual reports of its progress toward requiring such testing. These reports will describe the reasons for the delay and provide an estimate of when EPA will start requiring testing.

9. EPA agrees to keep the public informed of all results of priority setting, screening, and testing by publishing these results in a centralized place that is readily accessible to the general public.

IV.  MODIFICATION

10. If a subsequent change in law alters or relieves EPA of its obligations concerning matters addressed in this Settlement Agreement, then the Settlement Agreement shall be amended to conform to such changes.  Any dispute regarding invocation of this provision shall be resolved in accordance with the dispute resolution provision of Paragraph 12.

V.  FORCE MAJEURE

11. The Parties recognize that performance under this Settlement Agreement is subject to fiscal and procurement laws and regulations of the United States which include, but are not limited to, the Anti-Deficiency Act, 31 U.S.C.  1341, et seq.  A force majeure event may arise, due to circumstances outside the reasonable control of EPA, that could delay compliance with the obligations set forth in Paragraphs 3 through 9 of this Settlement Agreement.  Such force majeure events include, but are not limited to, a government shutdown, such as occurred in 1995 and 1996, or catastrophic environmental events requiring immediate and/or time-consuming response by EPA.  Emergency exemptions under section 18 of FIFRA shall not constitute a force majeure event for purposes of this Paragraph.  Should a delay occur due to a force majeure event, any resulting failure to fulfill any obligations set forth herein shall not constitute a failure to comply with the terms of this Settlement Agreement, and any deadlines so affected shall be extended one day for each day of the delay.  As soon as possible under such circumstances, EPA will provide Plaintiffs with notice invoking the relief provided for under this Paragraph, with an explanation of EPA's basis for invoking this relief.  EPA shall also provide Plaintiffs with reasonable notice of the termination of the force majeure event upon which EPA invoked this relief.  Any dispute regarding invocation of such relief shall be resolved in accordance with the dispute resolution provision of Paragraph 12 of this Settlement Agreement.

VI. DISPUTE RESOLUTION AND REMEDY FOR NONCOMPLIANCE

12. In the event of a disagreement between the parties concerning the interpretation or performance of any aspect of this Settlement Agreement, the dissatisfied party shall provide the other party with written notice of the dispute and a request for negotiations.  The parties shall meet and confer in order to attempt to resolve the dispute within 30 days of the written notice, or such time thereafter as is mutually agreed.  If the parties are unable to resolve the dispute within 60 days of such meeting, then Plaintiffs' may initiate an appropriate action at law.  EPA does not waive or limit any defense relating to such litigation.  Nothing in this Settlement Agreement alters or affects the standards for, or availability of,  judicial review of such an action. The Parties agree that contempt of court is not an available remedy under this Settlement Agreement.

13. Plaintiffs agree that they will not seek to enforce dates for implementation of the Endocrine Disruptor Screening Program that are earlier than those identified in Paragraphs 3, 4, 5, 7, and 8 of this Settlement Agreement either pursuant to FFDCA section 408(p) or any other authority.

VII.  AGENCY DISCRETION

14. Except as expressly provided herein, nothing in this Settlement Agreement shall be construed to limit or modify the discretion accorded EPA by the FFDCA, FIFRA, the APA, or general principles of administrative law.

15. Nothing in this Settlement Agreement shall bar EPA from acting on any matters covered in this Settlement Agreement in a time frame earlier than required by this Settlement Agreement or to take additional actions not specified herein if EPA determines such actions are appropriate under applicable law.

VIII.  COMPLIANCE WITH OTHER LAWS

16. Nothing in this Settlement Agreement shall be interpreted as or constitute a commitment or requirement that the United States obligate or pay funds in contravention of the Anti-Deficiency Act, 31 U.S.C.  1341, or take any action in contravention of the FFDCA, the Administrative Procedure Act, or any other law or regulation, either substantive or procedural.

IX.  USE OF THIS SETTLEMENT AGREEMENT

17. This Settlement Agreement shall not constitute an admission or evidence of any fact, wrongdoing, misconduct, or liability on the part of the United States, including without limitation, EPA, its officers, or any other person affiliated with it.

18. This Settlement Agreement constitutes the entire agreement of the Parties concerning the terms and obligations discussed herein and subject to dispute in Count Six of the First Amended Complaint in this action.  No other agreement shall govern the rights and/or obligations of the Plaintiffs and EPA with respect to the matters resolved by this Settlement Agreement, except in accordance with the terms stated herein.

X.  TERMINATION

19. This Settlement Agreement terminates Count Six in Plaintiffs' action against EPA.  Plaintiffs and Defendants agree jointly to move the Court to dismiss Count Six without prejudice.  

XI.  RELEASE

20. This Settlement Agreement constitutes a complete and final settlement (i.e., is in full satisfaction) of the claims asserted by Plaintiffs in Count Six, and all claims that Plaintiffs could have asserted with respect to the allegations of Count Six.

XII.  ATTORNEYS' FEES AND COSTS

21. The fees and costs provided for in the Consent Decree related to the other Counts in the Plaintiffs' complaint in this action shall constitute full settlement of any claims for fees and costs associated with Count 6 in their complaint. 

XIII.  APPLICABLE LAW

22. This Settlement Agreement shall be governed by and construed under the laws of the United States.

XIV.  MUTUAL DRAFTING

23. The Parties agree that this Settlement Agreement was jointly drafted by them.  Accordingly, the Parties agree that any and all rules of construction to the effect that ambiguity is construed against the drafting Party shall be inapplicable in any dispute concerning the terms, meaning, or interpretation of this Settlement Agreement.

XV.  THIRD-PARTY BENEFICIARIES

24. Nothing in this Settlement Agreement shall be construed to make any other person or entity not executing this Settlement Agreement a third-party beneficiary to this Settlement Agreement.  The Parties consent to the form, substance and entry of this Settlement Agreement.

XVI.  EFFECTIVE DATE

25. This Settlement Agreement shall become effective upon the date it has been signed by the Parties.  The Parties hereby agree to notify the court expeditiously that they have resolved Count six in the first amended complaint, and Plaintiffs and Defendants agree jointly to expeditiously move the court to dismiss the count.

XVII.  NOTICE AND CORRESPONDENCE

26. Any notice, including correspondence, required or made with respect to this Settlement Agreement, shall be in writing, effective upon receipt, and sent to the following persons, or to such other person or persons as any Party may subsequently identify (in accordance with this provision) to the other Parties:

For Plaintiffs:
Fred Altshuler
Altshuler, Berzon, Nussbaum, Rubin & Demain
177 Post Street
Suite 300
San Francisco, CA  94108

Erik Olson
Natural Resources Defense Council
1200 New York Avenue, N.W., Suite 400
Washington, DC  20005

For EPA:

Assistant General Counsel for Pesticides
Pesticides and Toxics Law Office
Office of General Counsel (2333A)
United States Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, D.C. 20004

Chief
Environmental Defense Section
Environment and Natural Resources Division
United States Department of Justice
P.O. Box 23986
Washington, D.C. 20026-3986
Attn:  DJ # 1-05728

XVIII.  COUNTERPARTS

27. This Settlement Agreement may be executed in any number of counterpart originals, each of which shall be deemed to constitute an original agreement, and all of which shall constitute one agreement.  The execution of one counterpart by any Party shall have the same force and effect as if that Party had signed all other counterparts.

XIX.  REPRESENTATIVE AUTHORITY

28. Each undersigned representative of the Parties to this Settlement Agreement certifies that he or she is fully authorized by the Party he or she represents to enter into and execute the terms and conditions of this Settlement Agreement, and to legally bind such Party to this Settlement Agreement.  By the signatures below, the Parties consent to entry of this Settlement Agreement.

FOR PLAINTIFFS:

FOR EPA:
ATTACHMENT A

EPA'S PLANNED PROCESS FOR VALIDATING THE SCREENS AND TESTS
PROPOSED FOR INCLUSION IN ITS ENDOCRINE DISRUPTOR
SCREENING PROGRAM

This Attachment describes  the Validation process that EPA currently intends to follow when validating the screens and tests that comprise the Endocrine Disruptor Screening Program.  Nothing in this Attachment limits EPA's discretion to vary from this process.

1. Method Development -- Screening assays and test method draft protocols will be developed by EPA, or adapted from existing OPPTS and/or OECD test guidelines, the literature, or expert judgement.  A Background Review Document (BRD) addressing all critical areas outlined in Validation and Regulatory Acceptance of Toxicological Test Methods (NIEHS 1997) will be prepared for each method to explain the relevant principles, methods and techniques. 

2. Pre-validation -- This phase will include a demonstration of the relevance and feasibility of using the draft protocol for the appropriate screening or  test method in a single laboratory, and will also provide data on intra-laboratory variability.  Pre-validation will provide appropriate procedural details necessary for developing  a standardized, optimized  protocol for inter-laboratory Validation and evaluation of additional appropriate reference chemicals.  Where sufficient experience and data exist for a particular method,  and are documented in the BRD, the review and analysis of existing data may be used in lieu of a demonstration study to optimize the protocol.

3. Determination of Readiness for Validation -- Upon completion of the development of the appropriate pre-validation data, EPA will consult with ICCVAM prior to initiating the inter-laboratory Validation of a protocol.  EPA will provide copies of the BRD, pre-validation report, standardized protocol and Validation study plan to ICCVAM  for review and comment prior to the beginning of Validation.

4. Validation--In the Validation phase, the standardized protocol will be conducted  with appropriate reference chemicals and  in multiple laboratories to demonstrate its general utility and inter-laboratory variability.  EPA will summarize the data, determine inter-laboratory variability and prepare a Validation report for subsequent peer review.

5. Peer Review -- The joint  FIFRA Scientific Advisory Panel/EPA Science Advisory Board Subcommittee (which was created two years ago to review the work of the Agency as it developed the proposal for its screening program), supplemented, as needed, by appropriate assay-specific experts, will conduct a peer review of the Validation study results for each assay.  The documents involved in this review are the BRD, pre-Validation report, Validation report, and standardized protocol.  ICCVAM will also receive the documents prepared for peer review on an FYI basis and have an opportunity to submit comments. ICCVAM also will be asked to provide nominations for the expert panels.  At the conclusion of peer review, ICCVAM will receive the final guideline and a report of the SAP/SAB peer review panel.

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