June 21 , 2011

Dr. Steve Bradbury Director EPA Office of Pesticide Programs US EPA Headquarters Ariel Rios Building 1200 Pennsylvania Ave., NW Mail Code: 7501P Washington, D.C. 20460

Mr. Frank Sanders Director EPA Office of Science Coordination a nd Policy US EPA Headquarters Ariel Rios Building 1200 Pennsylvania Ave., NW Mail Code: 7201M Washington, D.C. 20460

Dear Dr. Bradbury and Mr. Sanders : As you know, the Environmental Protection Agency has begun implement ation of the Endocrine Disruptor Screening Program (EDSP) that was developed pursuant to the Food Quality Protection Act of 1996 and amendments to the Safe Drinking Water Act

. Congress instructed EPA to determine the potential endocrine

- disrupting effects of pesticide chemicals and othe r substances, and based on those findings, to take action necessary to protect the public health. Congress mandated that EPA base its findings on “appropriate validated test systems and other scientifically relevant information” and “minimize duplicative testing.” Since that time, Congress, the Office of the President and EPA’s own Office of the Inspector General (“OIG”) have recognized that meaningful and timely gu idance to test order recipients explaining the criteria by which EPA will make its decisi ons, is necessary to ensure scientifically sound determinations and meaningful oversight of the Program. However, EPA has failed to develop and publish the necessary guidance. As currently implemented, the Agency will be relying on the initial screening of sixty

- seven chemicals (“List 1 Chemicals”) to assess i ts EDSP screening battery, but has failed thus far to provide the needed guidance to the List 1 Chemical test or der recipients

. Nevertheless, before the List 1 Chemical screening data have been ana lyzed (or even produced), EPA is already beginning the process for screening additional chemicals(“List 2 Chemicals”). The value of the unique data

- rich history of the List 1 Chemicals to

the Program will be diminished unless the production and review of the List 1 Chemical screening data can be organized and conducted under a logical, systematic process, and reviewed and characterized before testing of List 2 Chemicals begins. For these reasons, CropLife America , Consumer Specialty Products Association a nd RISE (Responsible Industry for a Sound Environment ) , through the attached administrative petition , respectfully request s that EPA issue needed technical and programmatic guidance to ensure the success of the EDSP and that the EPA f ully analyze the List 1 screening data prior to the issuance of List 2 Chemical test orders . Specifically, the Agency should:

 P rovide scientifically valid, peer

- reviewed critical process and procedure guidance documents for Tier I screening;

 P rovide sufficient time for List 1 Chemical test order recipients to prepare and submit their Tier I screening results in compliance with that guidance , and ;

 F ully analyze the List 1 Chemical EDSP screening data, and revise Program guidance based on lessons learned prior to the issuance of List 2 Chemical test orders. We look forward to your response within 30 days to this petition.

Sincerely,

Jay J. Vroom President & CEO CropLife America

Chris topher Cathcart President & CEO Consumer Specialty Products Association

Aaron Hob bs President RISE (Responsible Industry for a Sound Environment)Enclosure : PETITION TO MAXIMIZE PRACTICAL UTILITY OF LIST 1

CHEMICALS SCREENED THROUGH EPA’S ENDOCRINE DISRUPTOR SCREENING PROGRAMPETITION TO MAXIMIZE PRACTICAL UTILITY OF LIST 1 CHEMICALS SCREENED THROUGH EPA’S ENDOCRINE DISRUPTOR SCREENING PROGRAM

The United States Environmental Protection Agency (“EPA” or the “Agency”) has begun implementation of its Endocrine Disruptor Sc reening Program (“EDSP” or the “Program”), established pursuant to the Food Quality Prot ection Act of 1996 (“FQPA”) and the 1996 Safe Drinking Water Act Amendments (“SDWA”). The FQPA and SDWA instructed EPA to determine the endocrine-disrupting potential of pesticide chemicals and certain drinking water chemicals and, based on those findings, to take actions necessary to protect the public health. Congress mandated that EPA base its findings on “appropriate validated test systems and other scientifically relevant information.” 1 Since that time, Congress, the Office of the President and EPA’s own Office of the Inspector General (“OIG” ) have recognized that meaningful and timely guidance to test order recipients, explaining the criteria by which EPA will make its decisions, is necessary to ensure scie ntifically sound determinations and m eaningful oversight of the Program by Congress and other inte rested stakeholders. EPA, however, has failed to develop and pub lish the necessary guidance. As currently implemented, the Agency will be relying on the initi al screening of sixty-seven chemicals (“List 1 Chemicals”) to further validate and assess its ED SP screening battery, but has failed thus far to provide the time or guidance to the List 1 Chemi cal test order recipients necessary to produce the most consistent or meaningful data. Nevertheless, before the List 1 Chemical screening data have been analyzed (or even produced), EPA is already beginning the process for screening additional chemicals (“List 2 Chemicals”). 2 The value of the unique data-rich history of the List

1 21 U.S.C. §§ 346a(p)(1); 42 U.S.C. § 300j-17. 2 Endocrine Disruptor Screening Program; Second List of Chemicals for Tier I Screening, 75 Fed. Reg. 70,248 (Nov. 17, 2010); Endocrine Disruptor Screening Program; Draft Policies and Procedures for Screening Safe2 1 Chemicals to the Program will be diminished unless the production and review of the List 1 Chemical screening data can be organized and conducted under a logical, systematic process,

and reviewed and characterized before testing of List 2 Chemicals begins.

In its review of the information collection request (“ICR”) associated with the EDSP screening of the List 1 Chemicals, the Office of Management and Budget’s Office of Information and Regulatory Affairs (“OIRA”) sp ecifically instructed EPA, as terms of clearance of the ICR 3

, to develop the necessary guidance and make use of the List 1 Chemical data. Nevertheless, to date, EPA has failed to follow OIRA’s instructions. More recently, EPA’s own OIG issued a May 3, 2011, report, “EPA’s Endocrine Disruptor Screening Program Should Establish Ma nagement Controls to Ensure More Timely Results” (the “OIG Report”), 4 criticizing, inter alia , EPA’s failure to “finalize . . . criteria to evaluate testing data.” 5 The OIG Report recognized the deve lopment and finalization of these criteria as necessary “so that EPA’s leadershi p, Congress, and the public can assess whether the goals and key activities of the [E DSP] are being achieved within reasonable cost and schedule.” 6 For these reasons, CropLife America (“CL A”), the Consumer Specialty Products Association (“CSPA” ® ) and Responsible Industry for a Sound Environment ® (“RISE”), petition

the EPA Administrator under the Paperwork Reduction Act (“PRA”) 7 , the Administrative

Procedure Act 8 and the Federal Food, Drug, and Cosmetic Act (“FFDCA”) 9 to bring the Program

Drinking Water Act Chemicals, 75 Fed. Reg. 70,558 (Nov. 17, 2010); Agency Information Collection Activities; Proposed Collection; Comment Request; Addendum for the Sec ond List of Chemicals; Ti er 1 Screening of Certain Chemicals; Notices, 75 Fed. Reg. 70,568 (Nov. 17, 2010). 3 ICR-OIRA Conclusion, OMB Control No. : 2070-0176; ICR Ref. No. 200904-2070-001, available at http://www.reginfo.gov/public/do/PR AViewICR?ref_nbr=200904-2070-001. 4 OIG Report, available at http://www.epa .gov/oig/reports/2011/20110503-11-P-0215.pdf 5 Id. , “ At A Glance .” 6 Id., at 13. 7 44 U.S.C. §§ 3501-3520. 8 5 U.S.C. §§ 551-559, 701-706 (requiring, in pertinent part, that “[e]ach agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule”).3 into conformity with congressional intent and federal rulemaking requirements. We respectfully request that EPA meet the speci fic requirements and follow the di rection of Congress, the terms

of clearance of the ICR issued in relation to the EDSP screening of List 1 Chemicals, and the recommendations of the OIG Report. Specifically, the Agency should: (1) provide scientifically valid, peer-reviewed critical pro cess and procedure guidance documen ts for Tier I screening; (2) provide sufficient time for List 1 Chemical test order recipients to prepare and submit their Tier I screening results in compliance with that guidan ce; and (3) fully analyze the List 1 Chemical EDSP screening data, and revise Program guida nce based on lessons learned prior to the

issuance of List 2 Chemical test orders. We are not suggesting a specific time component as we respect the scientific and progr ammatic vetting requested depe nds upon resource allocations and stakeholder input. We have previously communicated with EPA on the issues addressed in this petition, and we are aware that EPA is in the pr ocess of reviewing public comment on, e.g., its Weight of the Evidence (“WoE”) Approach and its programma tic proposals regarding List 2 Chemicals. 10 Nevertheless, due to the time cons traints on List 1 Chemical test order recipients, some of whom must satisfy pending test orders by October 2011, we submit this petition now to encourage the Agency to heed the direction of Congress, OIRA and the OIG Report and a ddress these issues in a timeframe that might provide meaningful relief and due process to all List 1 Chemical test order recipients.

9 21 U.S.C. §§ 301-399. The First Amendment of the U.S. Constitution provides an independent basis for submission of this petition. U.S. C ONST . amend. I (“Congress shall make no law ... abridging ... the right of the people ... to petition the government for a redress of grievances.”). 10 Endocrine Disruptor Screening Program (EDSP); Announc ing the Availability of a Draft for Weight-of-Evidence Guidance Document: Evaluating Results of EDSP Tier 1 Screening To Identify Candid ate Chemicals for Tier 2 Testing, 75 Fed. Reg. 67,963 (Nov. 4, 2010); see n.2, 75 Fed. Reg. at 70,248.4 I. BACKGROUND A. PETITIONERS CLA is a not-for-profit trade organization th at represents developers, manufacturers, formulators, and distributors of plant science solutions for agri culture and pest management in the United States. CLA’s member companies pro duce, sell and distribut e virtually all the crop protection technology products used by American farmers and other consumers. CLA is committed to the safe and responsible use of the industry’s products in order to provide safe and abundant food, as well as for the control of insect and plant disease vectors for the protection of human health, all providing valuable be nefits back to the consumer. CSPA is the premier trade association repr esenting the interests of approximately 240 companies engaged in the manufacture, formula tion, distribution and sale of approximately $80 billion annually in the U.S. of hundreds of fa miliar consumer products that help household and

institutional customers create cleaner and healthier environm ents. CSPA products include disinfectants that kill germs in homes, hospitals and restaurants; candles, and fragrances and air fresheners that eliminate odors; pest manageme nt products for home, ga rden and pets; cleaning products and polishes for use throughout the home and institutions; products used to protect and improve the performance and appearance of auto mobiles; aerosol products and a host of other products used every day. Through its pr oduct stewardship program, Product Care ® , and scientific and business-to-business endeavors, CSPA provi des its members a platform to effectively address issues regarding the health, safety, sust ainability and environmental impacts of their products. RISE is a national not-for-pro fit trade asso ciation representing mo re than 225 producers and suppliers of specialty pesticide and fertiliz er products to both the pr ofessional and consumer markets. RISE member companies manufacture mo re than 90 percent of domestically produced5 specialty pesticides and fertilizers used in the United States, including consumer lawn and garden, golf course, professional turf and la wn care, greenhouse and nursery products. CLA, CSPA and RISE have provided comment to the Agency throughout the development of the EDSP. B. STATUTORY AND ADMINISTRATIVE BACKGROUND The FQPA amended the FFDCA and the Federa l Insecticide, Fungici de, and Rodenticide Act (“FIFRA”). 11 As, amended, FFDCA § 408(p) requires EPA to “develop a screening program, using appropriate validate d test systems and other scientif ically relevant information, to determine whether certain substances may have an e ffect in humans that is similar to an effect produced by naturally occurring estrogen, or such other endocrine effect as the Administrator may designate.” 12 Congress also directed that “[t]o the extent practicable the Administrator shall minimize duplicative testing of the same s ubstance for the same endocrine effect ....” 13 Additionally, the SDWA authorized EDSP screening pursuant to the FQPA for certain chemicals found in drinking water. 14 The PRA was passed in 1995 to minimize the paperwork burden for persons resulting from the collection of information by or for th e federal government, to ensure the greatest possible public benefit from, and maximize the utility of, informati on created, collected, maintained, used, shared and disseminated by or for the federal government, and to improve the quality and use of federal information to strengthen decisionmaking, accountability, and openness in government and society. 15 The PRA and its implementing regulations require all federal agencies to submit all co llections of information from th e public (such as the EDSP test

11 Food Quality Protection Act of 1996, Pub. L. No. 104-170, 110 Stat. 1489 (1996). 12 21 U.S.C. § 346a(p)(1). 13 Id. at § 346a(p)(5)(B). 14 42 U.S.C. § 300j-17. 15 See 44 U.S.C. § 3501.6 orders) for OIRA review, and authorize OIRA to provide instruction to the agencies to make substantive or material changes to an ICR as a term of OIRA clearance. 16 More recently, President Obama has called fo r improved regulations. In particular,

President Obama issued Executive Order 13563, “Improving Regulation and Regulatory Review,” on January 18, 2011. 17 The Executive Order recognized that government regulation must balance costs and benefits, must be ground ed on the best available science, and must promote predictability: Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation. It must be based on the best available science. It must allow for public participation and an open exchange of ideas. It must promote predictability and reduce uncertainty. It must id entify and use the best, most innovative, and least burdensome tools for achieving regulatory ends. It must take into account benefits and costs, both quantitative and qualitative. 18

C. REGULATORY AND FACTUAL BACKGROUND Following passage of the FQPA, EPA devel oped a two-tiered screening and testing Program to identify and characterize so-called “e ndocrine disruptors.” EP A’s stated purpose of the Tier I (“screening”) process is to: identify substances that have th e potential to interact with the estrogen, androgen, or thyroid horm one systems using a battery of assays. The fact that a substa nce may interact with a hormone system, however, does not mean that when the substance is used, it will cause adverse effects in humans or ecological systems. The purpose of Tier II testing (referred to as “testing”) is to identify and establish a dose-response relationship for any adverse effects that might result from the interactions identified through the Tier 1 assays .... 19

16 35 U.S.C. § 3507; 5 C.F.R. § 1320.10(b). 17 76 Fed. Reg. 3821 (Jan. 21, 2011). 18 Id. 19 Endocrine Disruptor Screening Program; Policies an d Procedures for Initial Screening (“Final Policies and Procedures”), 74 Fed. Reg. 17,559, 17,561 (Apr. 15, 2009).7 Additionally, after Congress passed the FQPA and SDWA amendments in 1996, EPA asked the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (“SAP”) and EPA’s Science Advisory Board (“SAB”) to form a jo int subcommittee to review a set of scientific issues concerning the development of the EDSP. The joint subcommittee also evaluated the recommendations from an expert committee formed on endocrine disruptors in its 1999 report. The subcommittee supported the expert’s recommendation that EPA evaluate potential endocrine disruptors for estrogenic, androgenic, and thyroid hormone effects, but cautioned EPA against expanding to additional hormone systems until know ledge of these systems and assay techniques matured. The joint subcommittee also recommended that EPA review screening data for 50 to 100 compounds, revise its process as necessary, and eliminate methods that do not work. 20 The OIG Report chronicles the impediment s in implementation of the EDSP, citing

EPA’s lack of awareness of the complexities, resources, and time inherent in validating assays, problems hiring contractors and difficulties w ith contractors being unable to do the work

needed. 21 Despite these difficulties in developing the Program, EPA described its priority setting approach to select pesticide chemical s as List 1 Chemicals on September 27, 2005. 22 In 2007, the Agency then published draft policies and proc edures for the Tier I screening process for public notice and comment. 23 The Agency published its Final Policies and Procedures in April 2009, 24 and issued test orders for Tier I screeni ng of the sixty-seven Li st 1 Chemicals beginning

20 Review of the EPA’S Proposed Environmental Endocrine Disruptor Screening Program, EPA-SAB-EC-99-013 , available at http://www.epa.gov/endo/pubs/sab_sap_report.pdf. 21 See n.4, supra at 9-14. 22 Endocrine Disruptor Screening Program; Chemical Selectio n Approach for Initial Screening, 70 Fed. Reg. 56,449 (Sept. 27, 2005). 23 Endocrine Disruptor Screening Program; Draft Polic ies and Procedures for Initial Screening; Request for Comment, 72 Fed. Reg. 70,842 (Dec. 13, 2007). 24 See n.19, 74 Fed. Reg. at 17,559.8 in October 2009. 25 In compliance with the PRA, EPA submitted an ICR associated with those

test orders to OIRA for review and approval. 26

1. OIRA Instructs EPA to Provide Peer-reviewed Screening Criteria OIRA did not simply rubber stamp EPA’s ICR. Instead, OIRA gave specific instruction to the Agency relating to the development and timing of specific, peer-reviewed guidance as to

how EPA would determine whether Tier II testing would be required: This information collection is approved for the 67 chemicals published by EPA at 74 Fed. Reg. 17579 (April 15, 2009). OMB appreciates the continuing dialog with respect to the practical utility of the Tier I battery of EDSP assays and the role that the results from these first 67 ch emicals will play in ensuring practical utility for subsequent groups of chemicals . Nonetheless, under the principles of the PRA, EPA should promote and encourage test order recipients to submit Other Scientifically Relevant Information (OSRI) in lieu of performing all or some of the Tier I assays, and EPA should accept OSRI as sufficient to satisfy the test orders to the gr eatest extent possible. For this reason, and to further validate EPA’s burden estimates, OMB requests that EPA provide a report re-estimating the burden of this information collection based on respons es to the Tier I test orders, including the use of cost-sha ring and data compensation, the submission and acceptance of existing data and OSRI, and description of any instances in which submission of OSRI was deemed insufficient to satisfy the testing order. OMB requests this report prior to or at the time of submission of revision of this information collection to cover ad ditional chemicals. In addition, in order to ensure that EPA has maximized the practical utility of the Tier I assays as the program moves forward, EPA should ensure sufficient opportunity prior to submission of any revision to this collection for public comment and peer review of the EPA tools to be developed to guide agency decisions on whether a

25 Endocrine Disruptor Screening Program; Tier I Screening Order Issuing Announcement, 74 Fed. Reg. 54,422 (Oct. 21, 2009); see, e.g., http://www.epa.gov/scipoly/oscpendo/pubs/sample_EDSP_Order_PAIs.pdf, http://www.epa.gov/scipoly/oscpendo/ pubs/sample_EDSP_Order_Inerts.pdf. 26 Agency Information Collection Activities; Submission To OMB for Review and Approval; Comment Request; Tier I Screening of Certain Chemicals Under the Endo crine Disruptor Screening Pr ogram (EDSP); EPA ICR No. 2249.01, OMB Control No. 2070-New, 74 Fed. Reg. 17477 (Apr. 15, 2009).9 chemical must proceed to Tier II, including the Weight of the Evidence Approach and Standard Evaluation Procedures

. 27 2. Congress Directs EPA to Provide Screening Criteria The Office of the President, through OIRA, was not the only federal stakeholder directing EPA to provide criteria by which the Agency would evaluate EDSP data. Congress directed

EPA to take this action on the EDSP in the House Appropriations Committee report for EPA’s FY2010 appropriations. 28 Specifically, Congress directed EPA to, inter alia , develop and publish criteria for evaluati ng Tier I screening data: Endocrine Disrupting Chemicals. --The Committee continues to have a strong interest in EPA’s efforts to assess the impact of endocrine disrupting chemicals on the environment and on human health. In reviewing the progre ss EPA has made to date, the Committee now directs EPA to: * * * (2) Develop and publish criteria for evaluating the results of Tier I screening and determining whethe r a chemical should undergo Tier II analysis within one year of enactment. The process should allow for public input. 29

3. OIG Recommends that EPA Finalize Specific Screening and Testing Criteria The recent OIG Report continues the drumb eat of calls for EPA’s development of meaningful screening criteria to maximize scientif ic integrity and to maximize the efficiency of the Program: After nearly 14 years, and after ha ving issued test orders for the first 67 chemicals to undergo Tier I screening, EPA has neither finalized specific criteria for ev aluating chemicals after Tier I screening is completed, nor esta blished specific criteria for

27 Note 3, supra , ICR-OIRA Conclusion, OMB Control No. : 2070-0176; ICR Ref. No. 200904-2070-001, available at http://www.reginfo.gov/public/do/ PRAViewICR?ref_nbr=200904-2070-001. 28 H.R. Rep. No. 111-180 at 105 (2009). 29 Id.10 evaluating chemicals after Tier II testing is completed, including carrying out the hazard asse ssment phase of the program. * * * EPA is scheduled to begin receiv ing Tier I screening data from industry in October 2011. If EPA do es not finalize specific criteria before then, the Agency will receive Tier 1 test order data without having formal procedures to evaluat e it, increasing the risk of the appearance of bias 30 and further delaying program results . We believe the program should have established criteria for the evaluation of chemicals and should not have had to be prompted by Congress to do so. 31

II. ARGUMENT As repeatedly stated in earlier submissions to the Agency, CLA, CSPA and RISE fully support the goals of the EDSP and do not seek to impede the progress of the Program. Rather, we seek through this petition to assist the Agency in the develo pment, review and evaluation of meaningful scientific data, procedures and guidance that can allow the Program to meet the intentions of Congress. We cannot overstate th e importance of a scientif ically valid conclusion of any chemical’s EDSP review, and of EPA’s clear communicati on to the public of the EDSP process and results. All stakeholders must be able to rely on the scientific integrity of the information produced through this process. False positives, or public misperception of the Program and chemicals going through it, can result in needless fear and di strust of specific

chemicals or entire industries. These are the very concerns th at led Congress in 1978 to require EPA to have a scientifically valid basis before initiating an administrativ e review of a pesticide

or its uses. 32

30 See n.4, supra , at 15 (The OIG notes, “Potential exists for the Ag ency to be accused of bias if it waits until after it sees the data to decide how it will proceed.”). 31 Id. 32 See 7 U.S.C. § 136a(c)(8)11 As mentioned above, Congress, OIRA, and EP A’s OIG have recognized the need for the publication of timely, scientifically valid screenin g criteria to maximize the practical utility and scientific integrity of the entire EDSP. Pr oviding scientific and programmatic guidance and adequate time in which to perform the List 1 Chemical screening assays, and to review and

evaluate the results in accordan ce with that guidance, is the most efficient, effective way in which to meet this need. As discussed below, th is approach best meets the shared goals of all stakeholders: providing meani ngful, accurate information to the public without undue burden on industry or EPA resources. Additionally, providi ng scientific and programmatic guidance offers a tremendous opportunity to avoid redundant testing, and in particular to prevent the unnecessary and wasteful use of laboratory animals. A. EPA’S ANALYSIS OF LIST I CHEMICAL DATA MUST MAXIMIZE ITS PRACTICAL UTILITY. The unique testing history and data associated with the List 1 Chemicals can and should

be used to validate EPA’s initial use of the Program’s screening battery. Nevertheless, EPA appears to be squandering the opportunity to make most effective use of the List 1 Chemicals

and the data that has been and will be created regarding them. In its administration of the Program thus far, EPA has failed to provide guidance fundamental to the development, submission and evaluation of meaningful data for pur poses of Tier I screeni ng. In the absence of that guidance, test order recipi ents are likely to develop and interpret data with conflicting, potentially contradictory interpretations and pr esentations, thereby incr easing EPA’s analytical burden, requiring re-submissions of data, and impeding the ultimate goals of the Program. 1. Recognized Role of List 1 Chemicals EPA, OIRA and the industry have all recogni zed that the data-rich pesticides comprising

List 1 Chemicals will be used to validate the Tier I assays. EPA has admitted as much in12 scientific documents supporting the Program, stating, for exampl e, that the data generated through the List 1 Chemicals w ill exceed the amount of data th at could be generated by a validation program, and that the List 1 Chemical screening results “may enhance confidence in the assays or prompt a reanalysis of its [sic] validation status.” 33 Similarly, OIRA has noted “the practical utility of the Tier I battery of EDSP assays and

the role that the results from the List 1 Chem icals will play in ensuri ng practical utility for subsequent groups of chemicals.” 34 We have highlighted in prior communications with the Agency the quantity and quality of endocrine-rela ted data on file with EPA for all pesticides. 35 To make the most effective use of the unique ex isting data set of the List 1 Chemicals, EPA should use these pesticidal data (required and accepted by EPA for all pesticidal chemicals) to develop specific, meaningful guidance with which it will evaluate the List 1 Chemical screening data, setting forth in the most transparent, scien tifically sound way exactly how the List 1 Chemical screening assays shoul d be interprete d and presented. If List 1 Chemical screening data can be submitted in a uniform, meaningful manner, EPA can then analyze those data, in the context of its existing pesticidal data sets, to determine if changes should be made to future test orders to make them more informative or efficient. The

33 EPA, Validation of Screening and Testing Assays Prop osed for the EDSP, 19 (July 16, 2007), available at http://www.epa.gov/scipoly/oscpendo/pubs/edsp_validation_paper_v%205.4.pdf ; see also, e.g., n.20, 70 Fed. Reg. at 56,453. 34 Note 3, supra. 35 Pesticidal crop protection products are subject to more than 100 health, safety and environmental tests to ensure their safety and effectiveness before these products are registered by the EPA. Th eir use and development are regulated by the EPA primarily under FIFRA and the FFDCA. Under FIFRA, EPA is required to ensure that each pesticide “will perform its intended functi on without unreasonable adverse effect s on the environment.” 7 U.S.C. § 136a(c)(5)(C). In order to meet this standard, every new crop protection product is evaluated for potential effects to humans, wildlife, plants and other organisms. It is esse ntial to understand the importance of evaluating both hazard (chemical properties, including toxicity) and exposure (amount, frequency and length of exposure to a chemical) in assessing risk before approval for the use of a product can be granted. FFDCA further requires EPA to make the determination “that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue” in foods. 21 U.S.C. § 346a(b)(2)(A)(ii). In the registration process, EPA evaluates the pesticide residues likely to occur in foods, other potential human expo sures and the toxicity of the chemicals to assure that the products meet this standard. See EPA-HQ-OPPT-2007-1080-0035 (CLA’s July 11, 2008 Petition for a Scientifically Sound and Legally Valid Endocrine Disruptor Screening Program).13 time and resources spent in carefully analyzing the results of the List 1 Chemical screening data and refining the Agency’s screeni ng criteria and guidance documents prior to the issuance of future test orders will help to create a more informa tive, efficient Program moving forward. Furthermore, EPA has also indicated the List 1 results will be used to validate future programs such as ToxCast, which further emphasizes the crit icality of careful interpretation of the results.

2. EPA Has Failed to Produce Tec hnical and Programmatic Guidance Required for the Efficient and Effective Development and Evaluation of Data Congress, OIRA and the OIG have directed EPA to publish criteria by which screening data will be evaluated. Such gui dance is necessary for the effici ent production of useful data. As the examples below illustrate, EPA has thus far failed to provide meaningful guidance on this

issue. a. Weight of the Evidence Approach On November 4, 2010, EPA announced the availa bility of a draft Weight-of-Evidence Guidance Document: Evaluating Results of ED SP Tier I Screening to Identify Candidate Chemicals for Tier II Testing (“Draft WoE Guidance”). 36 The Draft WoE Guidance EPA produced is more properly characterized as introd uctory material that might precede an actual guidance document for conducting WoE evaluations on results of the EDSP screening battery. In the Federal Register notice announcing the availability of the Draft WoE Guidance, EPA stated that the “document was prepared to provide a transparent, scientific approach to set forth some general principles, criteria, and considerations EPA generally believes to be relevant using a WoE approach to evaluate data submitted,” in response to the Tier I screening process. 37 However, the lack of substantive scientific information and details contained in the Draft WoE

36 Note10, supra, 75 Fed. Reg. at 67,963. 37 Id. at 67,965.14 Guidance fails to provide sufficient substance an d detail to achieve the Agency’s goals of transparency and consistency. In comments we provided to EPA on the Draft WoE Guidance, we urged the Agency to significantly revise the Draft WoE Guidance to pr ovide specific and detailed guidance and to submit the revised version for peer review. 38 Specifically, we noted the Draft WoE Guidance’s absence of any actual scientific guidance useful for evaluating resu lts of Tier I screening assays or for identifying candidate chemicals for Tier II testing. The Draft WoE Guidance fails to provide a weighting system for the myriad endpoint s that will be measured in the Tier I assays, or any means by which individual studies or aspect s of those studies should be considered more or less significant than others. While the Draft WoE Guidance addresses the integration of data across the Tier I assay battery, it provides no detail as to what qualities are to be given more weight than others or how EPA will use th ese characterizations in a WoE evaluation. In order to provide meaningful EDSP results that will meet the goals of Congress and the Program, EPA is obligated to develop a thor ough scientific guidance document for conducting WoE evaluations of the Tier I screening ba ttery, including a clear delineation of guiding principles, clear criteria for ev aluating studies, and methods by wh ich the Agency will weigh the

evidence and reach conclusions. EPA should e xplain which assays and which endpoints merit the greatest weight for determining each pot ential hormonal activity, addressed by the Tier I screening battery, and where possible, recomme nd a quantitative weighting scheme. A strategy should also be developed for weighting each particular result in each assay based on the complete range of responses possible for the en dpoint as defined by the responses elicited by known positive and negative control chemicals. Finally, EPA should address how the pattern of responses for a test chemical can be integrat ed across assays to derive an overall WoE

38 EPA-HQ-OPPT-2010-0877 (CLA’s January 31, 2001 comments on the Draft WoE Guidance).15 determination indicating the potential of a test su bstance to interact with each hormonal pathway evaluated by the Tier I screening battery. Such details will lead to greater transparency, objectivity, and consistency of interpretations, an d will ultimately enhance the integrity of the EDSP program. Without a more detailed, peer reviewed explanation of how EPA will apply a WoE characterization, test order recipients w ill provide their own assessment of weight, characterization and interpretation of the data provided to the Agency. Because of the robust data existing for many of the List 1 Chemicals, combined with the validation of the screening battery, the Agency should make these determin ations and communicate them to the public for comment and peer review. In the absence of substantive guidance, List 1 Chemical test order recipients are devoting further resources to defining their own, potentially conflicting WoE propos als for the purposes of application by EPA, each of which w ill have to be considered and, if rejected, will then require further analysis (and perhaps furthe r screening) in order to provide the data EPA requires. With Chemical 1 test order deadlines approaching in October 2011, test order re cipients have no other

choice. b. Standard Evaluation Procedures OIRA similarly instructed EPA to publish, for public comment and peer review, Standard Evaluation Procedures (“SEPs”) fo r the Tier I screening battery; however, these have not been proposed. With the present October 2011 date by which some of the Tier I screening data for List 1 Chemicals are due, it is now impossi ble for EPA to propose draft SEPs, allow for meaningful comment and peer review, analyze p ublic and academic comment, and publish final in a timely manner. As a result, Tier I data must be produced, interpreted, submitted, and preliminarily reviewed by EPA without the benef it of SEPs – which provide critical guidance16 that would ensure the consistency of Agency review and for protocol development and data evaluation by the respondents. OIRA and the OI G Report recognized the value of these SEPs to the efficiency and scientific integrity of the Ti er I submissions. Continuing to impose deadlines

for Tier I submissions without th e benefit of scientific ally valid SEPs ignor es the concerns of OIRA and the OIG. Like the lack of meaningful WoE guidance, the lack of SEPs will contribute to inconsistent, confusing Tier I submissions that will, in turn, result in requests for additional information from EPA, further impedi ng the ultimate outcomes of the EDSP. c. Other Testing Guidance Necessary to Maximize Use of the List 1 Chemicals As stated in the Policies a nd Procedures for Initial Scr eening, EPA intends to use the same data submission procedures currently used for submitting other data in support of pesticide registrations, including the use of data evaluation formats, or temp lates, for the writing of data evaluation records (“DERs”). 39 These templates have been in use by EPA since 2002 for writing

DERs of studies submitted under FIFRA and FFDCA. 40 As stated in the Final Policies and Procedures, the Agency “intends to review and, as necessary, develop new or revised templates

before the deadlines for submissi on of the data under the EDSP.” 41 Despite EPA’s assurances, these DER templates do not yet exist. The lack of these forms not only le aves List 1 Chemical test order recipients without cl ear guidance as to the format in which to submit their screening results, but also without the insight into the Ag ency’s priorities regarding the data that these templates would provide. Again, this lack of gui dance is most likely to result in inconsistent, potentially conflicting submissions that will, in turn, lead to additional questions from the Agency and further negatively impact the Program.

39 See n. 19, supra , 74 Fed. Reg. at 17,574. 40 Id. 41 Id.17 EPA also added further data reporting format requests. EPA has stated that it would develop electronic data forms for the following six guidelines: 42

 OCSPP 890.1150: Androgen Receptor Bi nding (Rat Prostate Cytosol)

 OCSPP 890.1200: Aromatase

 OCSPP 890.1250: Estrogen Receptor Bindi ng Assay Using Rat Uterine Cytosol

 OCSPP 890.1400: Hershberger Bioassay 43

 OCSPP 890.1450: Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Female Rats

 OCSPP 890.1500: Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Male Rats Despite EPA’s assurances, these electronic data forms do not yet exist. This means that the Agency will not be able to effectively and e fficiently review the data submitted. Rather, the Agency will need to spend its limited resources reformatting data it receives into EPA’s chosen

format for evaluation. And as with the lack of DERs, the lack of these forms similarly leaves

List 1 Chemical test order reci pients without clear guidance as to EPA’s preferred submission format, and also without insight in to EPA’s priorities regarding the data that these electronic data forms would provide. Again, lack of guidance will most likely result in inconsistent, potentially conflicting submissions and additi onal questions or requests from the Agency and will further negatively impact the progress of the Program.

42 See OCSPP Harmonized Test Guidelines; Series 890 - Endocr ine Disruptor Screening Pr ogram Test Guidelines, available at http://www.epa.gov/ocspp/pubs/frs/publica tions/Test_Guidelines/series890.htm. 43 In the Hershberger bioassay test guideline, Section (i)1 stat es that data is requested in an electronic form. In the other five test guidelines there is a direct reference to data forms.18 d. OSRI Criteria In reliance on EPA’s discussion of its OSRI policy in the Final Policies and Procedures, 44 our member companies undertook various activities re lated to the identifica tion of OSRI to fulfill Tier I screening requirements. Examples of th ese activities included, bu t are not limited to: review of toxicology data devel oped under pesticide registration da ta requirements for relevance to EDSP, extensive literature searches and re view of published data, review of EPA ToxCast information, 45 and development of detailed and often lengt hy scientific rationales in support of

the utilization of the cited or submitted OSRI. 46 Despite the time and resources dedicated to these efforts, EPA has rejected the vast majority (over 75%) of OSRI submitted by test order recipients. 47 This high rejection rate is likely due to th e extremely limited OSRI evaluation guidance EPA has provided. 48 Even now, having received OSRI res ponses from EPA, stakeholders do not have a clear understanding of the framework EP A employs for OSRI evaluation. Each Agency response indicates that a ‘weight of evidence ’ evaluation was conducted, but EPA has not made public the methods the Agency has followed to conduct its ‘weight of ev idence’ evaluation. EPA should provide a scientifically disciplined and objective methodology for conducting a ‘weight of evidence’ evaluation by consid ering evidence of various study types, sources, and quality. Without clear criteria establishing EPA’s framew ork for evaluation, no test order recipient will

44 See n. 19, supra , 74 Fed. Reg. at 17,571-72. 45 See, e.g., EPA-HQ-OPP-2009-0634-0212 (April 12, 2010 2,4-D OSRI Rationale Submittal, totaling over 300 pages). 46 CLA has estimated the overall cost thus far to generate OSRI for List 1 Chemicals to be approximately $1,584,000. See EPA-HQ-OPPT-2007-1081-0037.2 (CLA & EPF’s Nov. 10, 2010 comment, “EDSP Tier I Screening: Preliminary Burden Report). 47 See EPA-HQ-OPP-2009-0634-0238 (CLA’s March 14, 2011 comment re. EPA’s OSRI utilization within EDSP and FIFRA); see also “Status of EDSP OSRI: Order Recipient Su bmissions and EPA Responses,” available at http://www.epa.gov/scipoly/oscpendo/ pubs/EDSP_OSRI_Response_Table.pdf

. 48 See EPA-HQ-OPPT-2007-1080-0032 (EPA’s Approach fo r Considering Other Scientifically Relevant Information (OSRI) under the Endocrine Di sruptor Screening Program (EDSP)).19 be able to predict either: 1) which studies EPA will not waive, or 2) which chemicals may proceed directly to Tier II tes ting. This lack of understanding fu rther encourages poor utilization of resources and impedes the Program. B. EPA SHOULD ALLOW SUFFICIEN T TIME FOR LIST 1 CHEMICALS TO BE SCREENED, AND THEIR DATA TO BE ANALYZED The guidance outlined above (including peer -reviewed WoE, SEPs, DERs, electronic data forms and OSRI criteria) can only be mean ingfully and efficiently applied to the List 1 Chemicals if those test order recipients are allowed the opportunity to conduct their screens pursuant to it. The lack of clear technical and programmatic guidance regarding the Program’s specific evaluation criteria, together with a patter n of Agency delay and policy reversals, warrant an extension of time in which to properly prep are and evaluate the List 1 Chemical screening data prior to issuance of further test orders.

1. EPA’s Test Order Deadlines Develo ped Independent of Scientifically Valid Guidance In the Final Policies and Procedures, EPA established a 24 month timeframe from the date of receipt of the test order, taking into account, inter alia , “estimated timeframes for planning, performing the tests and documenting results.” 49 This planning, performance and

documentation have been made more difficult w ithout the guidance documents discussed above. Moreover, List 1 Chemical test order recipients have had to wait months for even more basic information on the Program. For example, List 1 Chemical test order recipients had no formal response from EPA to questions from industry rega rding serious technical mistakes contained in

49 Note 19, supra , 74 Fed. Reg. at 17,574.20 the Tier I screening assays under Series 890 Test Guidelines until March 4, 2011, despite the fact

that some test order deadlines fall in October 2011, a mere seven months later. 50

EPA has also failed to account for lost time resulting from its treatment of OSRI. As discussed above, many List 1 Chemical test order recipients attempted to fulfill Tier I screening assay requirements with OSRI. After dedicati ng significant resources in to the development and assembly of OSRI, the test orde r recipients understandably deferre d the initiation of the Tier I screening studies until EPA determined whether the OSRI submitted would fulfill the requirements. The Agency’s extended review of OSRI, approximately 75% of which was denied, added considerably to industry’s burde n. The Agency significantly underestimated the time required to conduct its review of the OSRI submissions – in some cases EPA review of

OSRI lasted nine months. 51 EPA has failed to extend existi ng List 1 Chemical test order deadlines in recognition of the tim e spent by industry’s preparati on, and the Agency’s protracted consideration, of OSRI. 52 2. EPA’s Policy Reversal Regarding “Bypass” to Tier II Further confusion occurred regarding the ability of chemicals to proceed directly to Tier II without undergoing Tier I scr eening. EPA offered such a “bypa ss” option with the earliest OSRI responses (August 2010) and did not clarif y that it was an error until late October 2010, leaving some test order recipients misguided in considering this option. Even once the error was rectified, the consequences in ac cepting a “bypass option” were not clarified for another month. In fact, we believe that errors were made in the test orders themselves, as the bypass option was

50 Test order recipients submitted questions to the Agency in February 2010, resubmitted the same in July 2010 and discussed these points at an October 2010 workshop. However, the final answers to the questions were not provided until March 2011. http://www.epa.gov/scipoly/oscpen do/pubs/assayvalidation/clarificationdoc.pdf 51 See “Status of EDSP Orders/DCIs as of May 5, 2011,” available at http://www.epa.gov/scipoly/oscpendo/pubs/edsp_orders_status.pdf

. 52 See April 28, 2011 Letter from EPA to Dr. Wendelyn Jones, CLA, in response to EPA-HQ-OPP-2009-0634- 0236.1 (Dr. Jones’ March 3, 2011 letter re. Agency decisions on EDSP extension requests by industry and consortia), not yet available at EPA-HQ-OPP-2009-0634.21 not included as an option for test order recipi ents on the test order response forms and this absence is contrary to the Guidance issued in conjunction with the implementation of the

EDSP. 53, 54 This, and the later confusion created by the listing of the bypa ss option in response to test order recipient submissi ons, where the bypass option was surprisingly offered and then in some cases rescinded, effectively de layed the ability of test order recipients to move forward in the planning for conducting the Tier I screening ba ttery. Despite these difficulties, EPA has been consistently adverse to industry’s requests for de adline extensions for List 1 Chemical screening data. While Congress and OIG have criticized EPA’s delays in Program implementation, both have also emphasized the importance of the us e of published screening criteria to increase program efficiency and integrity. 55 EPA should not sacrifice the qua lity of the Program to meet arbitrary and capricious deadlines.

3. Issuance of Test Orders for List 2 Chemicals Is Premature As mentioned above, EPA has begun the proce ss to issue test orders for the List 2

Chemicals. 56 Premature issuance of test orders fo r List 2 Chemicals will likely result in unnecessary screening and unusable data. Requiring EDSP screen ing of additional chemicals before EPA has had an opportunity to learn fr om and further validate its existing assays and battery will also likely resu lt in an undue burden on industry and a misappropriation of the goal of the EDSP – the production of scientifically valid informati on on which to base public policy and decision-making. Additionally, rather than a premature issuance of test orders for List 2 chemicals, a step-wise approach that provides for scientific and polic y adjustments offers a

53 See sample test order, available at http://www.epa.gov/scipoly/oscpendo/ pubs/sample_EDSP_Order_PAIs.pdf 54 Note 19, supra , at 17,572. 55 See n.4 and n. 28, supra . 56 Note 2, supra.22 tremendous opportunity to avoid redundant testing and in particular to prevent the unnecessary and wasteful use of laboratory animals.

In order to maximize the value of the Pr ogram, while minimizing the burden it places on

the List 1 Chemical test order recipients and itself, EPA should provide clear, scientific and programmatic guidance to those test order reci pients on how the Agency intends to use and interpret the data being developed. Once that gui dance is given, the List 1 Chemical test order recipients should have adequate time to develop, evaluate and inte rpret the data in a meaningful manner. Finally, EPA should take the time necessary to analyze the List 1 Chemical data provided against the existing data in the Agency’s files relevant to the List 1 Chemicals. Only once the Agency has had the opportunity to fully validate the EDSP screening battery in the context of the List 1 Chemicals’ existing data sets and to refine its testing methodology should the Agency proceed with test orders for List 2 Ch emicals. To issue test orders for those List 2 Chemicals before EPA has the opportunity to make use of the data-rich List 1 Chemicals, and refine the Agency’s screening guidance documen ts, squanders the opportunity to make full use of the comprehensive and robust List 1 Chemi cals test data, imposes unnecessary burdens on industry, and ignores the instruct ion from Congress, OIRA and the OIG to develop meaningful criteria on which the Program will proceed. III. CONCLUSION For all of the foregoing reasons , we respectfully request that EPA issue guidance and allow time necessary for implementing the EDSP so as to ensure that the Program maximizes efficiency, minimizes unnecessary and repetiti ve testing, and utili zes sound science. Specifically, the Agency should: (1) provide scientific ally valid, peer-review ed critical process and procedure guidance documents for Tier I scr eening; (2) provide suffi cient time for List 1 Chemical test order recipients to prepare and submit their Tier I screening results in compliance23 with that guidance; and (3) fully analyze the Li st 1 Chemical EDSP scr eening data, and revise Program guidance based on lessons le arned prior to the issu ance of List 2 Chemi cal test orders.