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 and 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 implementation 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 other 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 guidance to 

test order recipients explaining the criteria by which EPA will make its decisions, 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 its EDSP screening battery, but has 

failed thus far to provide the needed guidance to the List 1 Chemical test order recipients. 

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”). 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

and RISE (Responsible Industry for a Sound Environment), through the attached 

administrative petition, respectfully requests that EPA issue needed technical and 

programmatic guidance to ensure the success of the EDSP and that the EPA fully analyze 

the List 1 screening data prior to the issuance of List 2 Chemical test orders. Specifically, 

the Agency should: 

 Provide scientifically valid, peer-reviewed critical process and procedure guidance 

documents for Tier I screening; 

 Provide sufficient time for List 1 Chemical test order recipients to prepare and submit 

their Tier I screening results in compliance with that guidance, and; 

 Fully 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

Christopher Cathcart 

President & CEO

Consumer Specialty Products Association

Aaron Hobbs

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 PROGRAM
PETITION 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 Screening Program (“EDSP” or the “Program”), 

established pursuant to the Food Quality Protection 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 scientifically sound determinations and meaningful oversight of the Program 

by Congress and other interested stakeholders. 

EPA, however, 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 further validate and assess its EDSP screening battery, but has failed thus far to 

provide the time or guidance to the List 1 Chemical 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 Safe 
2 

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”) specifically instructed EPA, as terms of clearance of the ICR3, 

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 Management 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 development and finalization of these 

criteria as necessary “so that EPA’s leadership, Congress, and the public can assess whether the 

goals and key activities of the [EDSP] are being achieved within reasonable cost and schedule.”6

For these reasons, CropLife America (“CLA”), 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 Act8

 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 Second List of Chemicals; Tier 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/PRAViewICR?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 specific requirements and follow the direction 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 process and procedure guidance documents 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 guidance; and (3) fully 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 are not suggesting a specific time component as we 

respect the scientific and programmatic vetting requested depends 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 process of reviewing public comment on, e.g., its Weight of the 

Evidence (“WoE”) Approach and its programmatic proposals regarding List 2 Chemicals.10 

Nevertheless, due to the time constraints 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 address 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. CONST. 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); Announcing the Availability of a Draft for Weight-of-Evidence 

Guidance Document: Evaluating Results of EDSP Tier 1 Screening To Identify Candidate 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 that represents developers, manufacturers, 

formulators, and distributors of plant science solutions for agriculture and pest management in 

the United States. CLA’s member companies produce, sell and distribute 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 benefits back to the consumer. 

CSPA is the premier trade association representing the interests of approximately 240 

companies engaged in the manufacture, formulation, distribution and sale of approximately $80 

billion annually in the U.S. of hundreds of familiar consumer products that help household and 

institutional customers create cleaner and healthier environments. CSPA products include 

disinfectants that kill germs in homes, hospitals and restaurants; candles, and fragrances and air 

fresheners that eliminate odors; pest management products for home, garden and pets; cleaning 

products and polishes for use throughout the home and institutions; products used to protect and 

improve the performance and appearance of automobiles; aerosol products and a host of other 

products used every day. Through its product stewardship program, Product Care®, and scientific 

and business-to-business endeavors, CSPA provides its members a platform to effectively 

address issues regarding the health, safety, sustainability and environmental impacts of their 

products. 

RISE is a national not-for-profit trade association representing more than 225 producers 

and suppliers of specialty pesticide and fertilizer products to both the professional and consumer 

markets. RISE member companies manufacture more than 90 percent of domestically produced 
5 

specialty pesticides and fertilizers used in the United States, including consumer lawn and 

garden, golf course, professional turf and lawn 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 Federal Insecticide, Fungicide, and Rodenticide 

Act (“FIFRA”).11 As, amended, FFDCA § 408(p) requires EPA to “develop a screening 

program, using appropriate validated test systems and other scientifically relevant information, to 

determine whether certain substances may have an effect 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 substance 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 the federal government, to ensure the greatest 

possible public benefit from, and maximize the utility of, information 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 collections of information from the 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 for 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 grounded 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 identify 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 developed a two-tiered screening and testing 

Program to identify and characterize so-called “endocrine disruptors.” EPA’s stated purpose of 

the Tier I (“screening”) process is to: 

identify substances that have the potential to interact with the 

estrogen, androgen, or thyroid hormone systems using a battery of 

assays. The fact that a substance 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 and 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 joint 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 knowledge 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 impediments 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 with 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 chemicals as List 1 Chemicals on September 27, 2005.22 In 2007, 

the Agency then published draft policies and procedures 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 screening of the sixty-seven List 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 Selection Approach for Initial Screening, 70 Fed. Reg. 56,449 

(Sept. 27, 2005). 

23 Endocrine Disruptor Screening Program; Draft Policies 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 chemicals 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 greatest 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 responses to the Tier I test orders, 

including the use of cost-sharing 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 additional 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 Endocrine Disruptor Screening Program (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 evaluating 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 progress 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 whether 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 drumbeat of calls for EPA’s development of 

meaningful screening criteria to maximize scientific integrity and to maximize the efficiency of 

the Program: 

After nearly 14 years, and after having issued test orders for the 

first 67 chemicals to undergo Tier I screening, EPA has neither 

finalized specific criteria for evaluating chemicals after Tier I 

screening is completed, nor established 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 assessment phase of the program. 

* * * 

EPA is scheduled to begin receiving Tier I screening data from 

industry in October 2011. If EPA does not finalize specific criteria 

before then, the Agency will receive Tier 1 test order data without 

having formal procedures to evaluate it, increasing the risk of the 

appearance of bias30 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 development, review and evaluation of 

meaningful scientific data, procedures and guidance that can allow the Program to meet the 

intentions of Congress. We cannot overstate the importance of a scientifically valid conclusion 

of any chemical’s EDSP review, and of EPA’s clear communication 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 distrust of specific 

chemicals or entire industries. These are the very concerns that led Congress in 1978 to require 

EPA to have a scientifically valid basis before initiating an administrative review of a pesticide 

or its uses.32 

                                                     

30 See n.4, supra, at 15 (The OIG notes, “Potential exists for the Agency 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 EPA’s OIG have recognized the need for the 

publication of timely, scientifically valid screening criteria to maximize the practical utility and 

scientific integrity of the entire EDSP. Providing 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 accordance with that guidance, is the most efficient, effective way in 

which to meet this need. As discussed below, this approach best meets the shared goals of all 

stakeholders: providing meaningful, accurate information to the public without undue burden on 

industry or EPA resources. Additionally, providing 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 purposes of Tier I screening. In the absence of 

that guidance, test order recipients are likely to develop and interpret data with conflicting, 

potentially contradictory interpretations and presentations, thereby increasing 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 recognized that the data-rich pesticides comprising 

List 1 Chemicals will be used to validate the Tier I assays. EPA has admitted as much in 
12 

scientific documents supporting the Program, stating, for example, that the data generated 

through the List 1 Chemicals will exceed the amount of data that 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 Chemicals will play in ensuring practical utility for 

subsequent groups of chemicals.”34 We have highlighted in prior communications with the 

Agency the quantity and quality of endocrine-related data on file with EPA for all pesticides.35 

To make the most effective use of the unique existing 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, scientifically sound way exactly how the List 1 

Chemical screening assays should be interpreted 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 Proposed 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. Their 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 function without unreasonable adverse effects 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 essential 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 exposures 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 screening criteria and guidance documents prior to the issuance of 

future test orders will help to create a more informative, 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 criticality of careful interpretation of the results. 

2. EPA Has Failed to Produce Technical 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 guidance is necessary for the efficient 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 availability of a draft Weight-of-Evidence 

Guidance Document: Evaluating Results of EDSP 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 introductory 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 and 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 provide 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 results 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 endpoints that will be measured in the Tier I assays, 

or any means by which individual studies or aspects 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 these 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 thorough scientific guidance document for conducting 

WoE evaluations of the Tier I screening battery, including a clear delineation of guiding 

principles, clear criteria for evaluating studies, and methods by which the Agency will weigh the 

evidence and reach conclusions. EPA should explain which assays and which endpoints merit 

the greatest weight for determining each potential hormonal activity, addressed by the Tier I 

screening battery, and where possible, recommend 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 endpoint 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 integrated 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 substance 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, and 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 will 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 determinations 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 proposals for the purposes of 

application by EPA, each of which will have to be considered and, if rejected, will then require 

further analysis (and perhaps further screening) in order to provide the data EPA requires. With 

Chemical 1 test order deadlines approaching in October 2011, test order recipients have no other 

choice. 

b. Standard Evaluation Procedures

OIRA similarly instructed EPA to publish, for public comment and peer review, Standard 

Evaluation Procedures (“SEPs”) for 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 impossible for EPA to propose draft SEPs, allow for 

meaningful comment and peer review, analyze public 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 benefit of SEPs – which provide critical guidance 
16 

that would ensure the consistency of Agency review and for protocol development and data 

evaluation by the respondents. OIRA and the OIG Report recognized the value of these SEPs to 

the efficiency and scientific integrity of the Tier I submissions. Continuing to impose deadlines 

for Tier I submissions without the benefit of scientifically valid SEPs ignores 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 impeding the ultimate outcomes of the EDSP. 

c. Other Testing Guidance Necessary to Maximize Use of 

the List 1 Chemicals

As stated in the Policies and Procedures for Initial Screening, 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 templates, 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 submission 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 leaves List 1 Chemical 

test order recipients without clear guidance as to the format in which to submit their screening 

results, but also without the insight into the Agency’s priorities regarding the data that these 

templates would provide. Again, this lack of guidance 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 Binding (Rat Prostate Cytosol) 

 OCSPP 890.1200: Aromatase 

 OCSPP 890.1250: Estrogen Receptor Binding Assay Using Rat Uterine Cytosol 

 OCSPP 890.1400: Hershberger Bioassay43

 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 efficiently 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 recipients without clear guidance as to EPA’s preferred submission 

format, and also without insight into 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 additional questions or requests from the Agency and will further 

negatively impact the progress of the Program. 

                                                     

42 See OCSPP Harmonized Test Guidelines; Series 890 - Endocrine Disruptor Screening Program Test Guidelines, 

available at 

http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series890.htm.

43 In the Hershberger bioassay test guideline, Section (i)1 states 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 related to the identification of OSRI to fulfill 

Tier I screening requirements. Examples of these activities included, but are not limited to: 

review of toxicology data developed under pesticide registration data requirements for relevance 

to EDSP, extensive literature searches and review of published data, review of EPA ToxCast 

information,45 and development of detailed and often lengthy 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 the extremely limited OSRI evaluation guidance 

EPA has provided.48 Even now, having received OSRI responses from EPA, stakeholders do not 

have a clear understanding of the framework EPA 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 evidence’ evaluation. EPA 

should provide a scientifically disciplined and objective methodology for conducting a ‘weight 

of evidence’ evaluation by considering evidence of various study types, sources, and quality. 

Without clear criteria establishing EPA’s framework 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 Submissions 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 for Considering Other Scientifically Relevant 

Information (OSRI) under the Endocrine Disruptor 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 testing. This lack of understanding further encourages poor utilization 

of resources and impedes the Program. 

B. EPA SHOULD ALLOW SUFFICIENT 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 meaningfully 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 pattern of Agency delay and policy reversals, warrant 

an extension of time in which to properly prepare and evaluate the List 1 Chemical screening 

data prior to issuance of further test orders. 

1. EPA’s Test Order Deadlines Developed 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 without 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 regarding 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 dedicating significant resources into the development and 

assembly of OSRI, the test order recipients understandably deferred 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 burden. 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 existing List 1 Chemical test order 

deadlines in recognition of the time spent by industry’s preparation, 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 screening. EPA offered such a “bypass” option with the earliest 

OSRI responses (August 2010) and did not clarify 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 accepting 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/oscpendo/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 recipients 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 bypass option in response 

to test order recipient submissions, where the bypass option was surprisingly offered and then in 

some cases rescinded, effectively delayed the ability of test order recipients to move forward in 

the planning for conducting the Tier I screening battery. Despite these difficulties, EPA has been 

consistently adverse to industry’s requests for deadline 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 use of published screening criteria to increase 

program efficiency and integrity.55 EPA should not sacrifice the quality 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 process to issue test orders for the List 2 

Chemicals.56 Premature issuance of test orders for List 2 Chemicals will likely result in 

unnecessary screening and unusable data. Requiring EDSP screening of additional chemicals 

before EPA has had an opportunity to learn from and further validate its existing assays and 

battery will also likely result in an undue burden on industry and a misappropriation of the goal 

of the EDSP – the production of scientifically valid information 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 policy 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 Program, 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 recipients on how the Agency intends to use and 

interpret the data being developed. Once that guidance is given, the List 1 Chemical test order 

recipients should have adequate time to develop, evaluate and interpret 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 Chemicals. 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 documents, squanders the opportunity to make full use 

of the comprehensive and robust List 1 Chemicals test data, imposes unnecessary burdens on 

industry, and ignores the instruction 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 repetitive testing, and utilizes sound science. 

Specifically, the Agency should: (1) provide scientifically valid, peer-reviewed critical process 

and procedure guidance documents 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 
23 

with that guidance; and (3) fully 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.